FDA 510(k) Application Details - K960236

Device Classification Name	Gauze/Sponge, Internal, X-Ray Detectable   More FDA Info for this Device
510(K) Number	K960236
Device Name	Gauze/Sponge, Internal, X-Ray Detectable
Applicant	CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 ORLANDO, FL 32811 US Other 510(k) Applications for this Company
Contact	RICHARD L ELLWOOD Other 510(k) Applications for this Contact
Regulation Number	878.4450   More FDA Info for this Regulation Number
Classification Product Code	GDY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/1996
Decision Date	03/28/1996
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