FDA 510(k) Application Details - K961454

Device Classification Name	Accessory, Surgical Apparel   More FDA Info for this Device
510(K) Number	K961454
Device Name	Accessory, Surgical Apparel
Applicant	AMERICAN MEDICAL MFG., INC. 9410 DESOTO AVE., UNIT J CHATSWORTH, CA 91311 US Other 510(k) Applications for this Company
Contact	MIKE HOFTMAN Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	LYU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/1996
Decision Date	07/25/1996
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