FDA 510(k) Application Details - K962144

Device Classification Name	System, Skin Closure   More FDA Info for this Device
510(K) Number	K962144
Device Name	System, Skin Closure
Applicant	PHOENIX BIOMEDICAL CORP. P.O. BOX 80390 NORRISTOWN, PA 19403 US Other 510(k) Applications for this Company
Contact	HORACE J WILMER Other 510(k) Applications for this Contact
Regulation Number	878.4320   More FDA Info for this Regulation Number
Classification Product Code	MKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/1996
Decision Date	01/14/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review