FDA 510(k) Application Details - K964846

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K964846
Device Name	Elastomer, Silicone, For Scar Management
Applicant	IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW WASHINGTON, DC 20006 US Other 510(k) Applications for this Company
Contact	EDWARD M BASILE, ESQ. Other 510(k) Applications for this Contact
Regulation Number	878.4025   More FDA Info for this Regulation Number
Classification Product Code	MDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/1996
Decision Date	02/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review