US FDA 510(k)

The US FDA technical guidance will be provided by the expert in the industry, for knowing the details of the consultant will be appointed for your product, please write us an e-mail.

Type of Device Guidance Fee Preparation of 510(K) Notification Submission Fee
Biocompatible device *** *** ***
Electromagnetic device *** *** ***
Radio Therapy equipments *** *** ***

US FDA Associated Fee
Activity FEE Annual Charges
Label Review *** NA
Establishment Registration *** NA
Device Listing *** NA
US Agent Fee *** ***

For “***”, Please contact us for proposal, Please mention about the product in detail ( Technical name of the product and its intended use and details of models), so that we can send you the proposal

  • Payments accepted in Indian rupees. Govt. taxes additional as applicable
  • for all the visits including site visit for technical discussion, travelling will be chargeable at actual.
  • Fee to be paid in 4 equal Instalments.
  • Method of communication - Telephone /e-mail
  • Language for communication – English.
  • Minimum Timeline - 90 Days for Submission file preparation from getting all necessary inputs from your side.

Contact us

A1-101, Ankur,
Near Cipla Foundation,
Warje, Pune- 411058

E mail :-
Telephone :- +91 - 9881946595

Design & Developed By : Logic Palace Systems and Softwares
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