FDA 510(k) Application Details - K961410

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K961410
Device Name	Elastomer, Silicone, For Scar Management
Applicant	THE S. F. GROUP, INC. 304 WEST MAIN ST. GRAND JUNCTION, CO 81505 US Other 510(k) Applications for this Company
Contact	PAULE STIEFLER 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	03/12/1996
Decision Date	09/03/1996
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