Full/Half Service - FDA 510(k) Request For Quote (RFQ)
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General and Manufacturer Information
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Product Information
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Administrative Information
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Contact Information
Company Name
Full Name
Telephone
General Information
Name of the Company
Contact Person
Job Title
Contact Number
Contact Email
Website Address
Manufacturer Information
Do you manufacture a complete device?
Do you manufacture a device which is a component for other medical device?
Do you manufacture and sell the medical device in your company name?
Do you only pack the manufactured device and sell in your company name?
Mention the company name and address to be printed on outer cover during shipment to USA
Mention the company name and address to REGISTER YOUR ESTABLISHMENT with US FDA
Product Information
Name of the Device for 510k Clearances
Where it is used in the human body?
Intended use of the medical device
Product Code if known
Product Regulation number if known
Name two comparative / predicative devices already taken 510k
Do you have any variant/variants for the device planning for 510(k)?
If yes, name the models
Main differences between models, please mention
Administrative Information
Technical Guidance
Document preparation
US Agent Service
Document Review
Submission to FDA
Is your Organization Implemented 21 CFR 820?
Is your Organization ISO 13485 Certified?
Is the device you are planning for 510k is CE Marked?
Do you have a person designated to coordinate with 510k submission?
If yes, mention his/her role, designation and experience
Attach the photograph of the product
Max. size: 32.0 MB
Upload product brochure/ manual / Specification/ IFU
Max. size: 32.0 MB