FDA 510(k) Application Details - K991604

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K991604
Device Name	Elastomer, Silicone, For Scar Management
Applicant	BIODERMIS CORP. 3078 EAST SUNSET RD. SUITE #1 LAS VEGAS, NV 89120 US Other 510(k) Applications for this Company
Contact	JEFF S SCHLEUNING 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	05/10/1999
Decision Date	06/09/1999
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