FDA 510(k) Application Details - K994053

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K994053
Device Name	Gown, Surgical
Applicant	STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. KALAMAZOO, MI 49001 US Other 510(k) Applications for this Company
Contact	SUSANNE VELAQUEZ 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	11/30/1999
Decision Date	12/20/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review