FDA 510(k) Application Details - K111733

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K111733
Device Name	Elastomer, Silicone, For Scar Management
Applicant	CORELEADER BIOTECH CO., LTD. 19F NO. 100, SEC 1 SINTAI 5TH RD, SIJHIH DIST NEW TAIPEI, TAIWAN 22102 TW Other 510(k) Applications for this Company
Contact	IAN LI 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	06/21/2011
Decision Date	09/22/2011
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