FDA 510(k) Application Details - K993170

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K993170
Device Name	Gown, Surgical
Applicant	MEDLINE INDUSTRIES, INC. 1170 NORTHPOINT BLVD. WAUKEGAN, IL 60085 US Other 510(k) Applications for this Company
Contact	BETTY A LOCK 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	09/22/1999
Decision Date	03/02/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review