FDA 510(k) Application Details - K964256

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K964256
Device Name	Wrap, Sterilization
Applicant	MADISON POLYMERIC ENGINEERING 495 WARD ST. EXTENSION WALLINGFORD, CT 06492 US Other 510(k) Applications for this Company
Contact	SHAUN SWEENEY Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/1996
Decision Date	05/06/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review