FDA 510(k) Application Details - K063005

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K063005
Device Name	Gown, Surgical
Applicant	STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. KALAMAZOO, MI 49001 US Other 510(k) Applications for this Company
Contact	PAULETTE D JOHNSON Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2006
Decision Date	03/23/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review