FDA 510(k) Application Details - K012419

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K012419
Device Name	Elastomer, Silicone, For Scar Management
Applicant	IMPLANTECH ASSOCIATES, INC. 2064 EASTMAN AVE., UNIT 101 VENTURA, CA 93003 US Other 510(k) Applications for this Company
Contact	STEPHEN MEADE 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	07/30/2001
Decision Date	10/24/2001
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