FDA 510(k) Application Details - K040707

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K040707
Device Name	Wrap, Sterilization
Applicant	VYGON US LLC 2495 GENERAL ARMSTEAD AVE. NORRISTOWN, PA 19403 US Other 510(k) Applications for this Company
Contact	COURTNEY SMITH 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	03/18/2004
Decision Date	04/16/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review