FDA 510(k) Application Details - K971482

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K971482
Device Name	Elastomer, Silicone, For Scar Management
Applicant	DEGANIA SILICONE, LTD. DEGANIA BET EMEK HAYARDEN 15130 IL Other 510(k) Applications for this Company
Contact	BETTE LUBIN 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	04/21/1997
Decision Date	06/24/1997
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