510(k) K925610

FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN by Microtek Medical, Inc. — Product Code FWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1994
Date Received
November 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type