Inquiry Form:

Which service are you enquiring about?

Medical Device Categorization Consultation on Medical Device Listing Submission Listing Submission for 510(k) Exempt Medical / Cosmetic Devices Submission of Applications for Medical Devices requiring 510(k) or PMA Submission of De Novo Device Applications i. a. FDAMA Clinical Testing Consultation for Class II and III Medical Devices In-House Spectral Analysis for Radiological Devices IR, MCR, and AR Submissions in accordance with 21 CFR 1040 Medical Device Production Record Maintenance Submission of Appeals for Reclassification Market Overview Research

 

Individual Name:		Company Name:
Address:		City:
State:		Zip:
Country:
Phone:		Fax:
Email:		Cell (optional):
The following questions deal with device listings
Is the product a Medical Device?		Yes	No
Can you provide us with a color brochure?		Yes	No
Can you provide us with an instruction manual?		Yes	No
Is there a website where we can see the product?		Yes	No
If yes, Please provide URL:
Has this product been sold previously in the US?		Yes	No
If yes, under what name?
Please give as much information as possible on the product including it's typical use:
Please allow up to 48 hours for a response.
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Contact Information:

AEGIS Regulatory P.A.

1131 Anthem View Lane

Knoxville, TN 37922

Phone: 865-982-5552
Fax: 865-381-1808
Website: www.fdalistingconsultants.com
Email: info@fdalistingconsultants.com