FDA 510(k) Application Details - K974354

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K974354
Device Name	Elastomer, Silicone, For Scar Management
Applicant	SCA MOLNLYCKE 500 BALDWIN TOWER EDDYSTONE, PA 19022 US Other 510(k) Applications for this Company
Contact	MIGUEL A NEGRON 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	11/19/1997
Decision Date	03/05/1998
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