FDA 510(k) Application Details - K063245

Device Classification Name	More FDA Info for this Device
510(K) Number	K063245
Device Name	ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
Applicant	BACTERIN INTERNATIONAL INC. 543 LONG HILL AVENUE SHELTON, CT 06484 US Other 510(k) Applications for this Company
Contact	JOSEPH M AZARY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2006
Decision Date	11/28/2007
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