Operon Strategist
Operon Strategist
Pimpri Colony, Pimpri Chinchwad, Maharashtra
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US FDA Certification Services

Service Provider of a wide range of services which include 510 (k) certification service, establishment registration and device listing service and usfda certification service.

510 (k) Certification Service

510 (k) Certification Service
  • 510 (k) Certification Service
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Service Details:

Minimum Order Quantity50 Unit
Preferred LocationIndia

510 (k) Certification Service of the Food, Drug, and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.

For class II devices, there is a process called the 510(k) process or the pre-market clearance. In this, the safety & effectiveness of the device is established through substantial equivalence. Operon Strategist helps the client in the classification of the device after consultation with the client. After conferring with the client, we establish the predicate device & testing requirements as per US FDA consensus standards. We help in the compilation of the 510(k) file, review of test reports, and submission of the file to US FDA & correspondence with US FDA. We also help in handling the queries raised by the US FDA reviewer. We support the client until they receive the 510(k) clearance letter.

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Establishment Registration and Device Listing Service

Establishment Registration and Device Listing Service
  • Establishment Registration and Device Listing Service
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Service Details:

Minimum Order Quantity2 Set
Company TypeMedical Industry
Company LocationIndia

As a reputed company in this industry, we are instrumental in offering Establishment Registration and Device Listing Service to our precious clients. The offered services are highly reliable and trustworthy among our esteemed patrons. We offer the expertise to help you set up new manufacturing unite as well as regulatory support to your facility and product.
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USFDA Certification Service

USFDA Certification Service
  • USFDA Certification Service
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Service Details:

Preferred LocationIndia
CertificationNew Certification
IndustryManufacturing, Chemical, Drug

Being a leading service provider in this domain, we are engaged in providing USFDA Certification Service in the US to our clients. This USFDA Certification Service is provided by expert professionals. This USFDA Certification Service is provided by our skilled professionals and responsible for protecting and promoting public health through the regulation and supervision of food and other relate items. Our service range is widely demanded in different regions.

Why US FDA

  • Any non US manufacturer of medical devices who wants to place his device in US market is required to register his facility and to list his products with US Food and drug administration before exporting to US. Before registration and listing his product he must obtain 510 K clearances for his devices (if applicable).
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Reach Us
Anil Chaudhari (Proprietor)
MSR Capital, Office No. 10, 3rd Floor, Old Mumbai Pune Highway Morwadi, Pimpri Colony
Pimpri Chinchwad- 411018, Maharashtra, India



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