FDA 510(k) Application Details - K960254

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K960254
Device Name	Elastomer, Silicone, For Scar Management
Applicant	ROFIL MEDICAL USA, INC. 26856 OAK HOLLOW RD. P.O. BOX 2036 LAGUNA HILLS, CA 92653-2036 US Other 510(k) Applications for this Company
Contact	WILLIAM E STOVALL 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	01/17/1996
Decision Date	04/02/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review