FDA 510(k) Application Details - K110318

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K110318
Device Name	Dressing, Wound, Collagen
Applicant	TISSUE REPAIR COMPANY 12255 EL CAMINO REAL SUITE 250 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	LOIS CHANDLER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2011
Decision Date	10/03/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review