FDA 510(k) Application Details - K023136

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K023136
Device Name	Elastomer, Silicone, For Scar Management
Applicant	BIO MED SCIENCES, INC. 1111 W. HAMILTON ST. ALLENTOWN, PA 18101 US Other 510(k) Applications for this Company
Contact	MARK E DILLON 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	09/20/2002
Decision Date	10/16/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review