3-D ACCUSCAN FACIAL IMPLANTS

Prosthesis, Chin, Internal

IMPLANTECH ASSOCIATES, INC.

The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for 3-d Accuscan Facial Implants.

Pre-market Notification Details

Device IDK913761
510k NumberK913761
Device Name:3-D ACCUSCAN FACIAL IMPLANTS
ClassificationProsthesis, Chin, Internal
Applicant IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington,  DC  20006
ContactDvorah A Richman
CorrespondentDvorah A Richman
IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington,  DC  20006
Product CodeFWP  
CFR Regulation Number878.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-21
Decision Date1991-10-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.