FDA 510(k) Application Details - K961791

Device Classification Name	Accessory, Surgical Apparel   More FDA Info for this Device
510(K) Number	K961791
Device Name	Accessory, Surgical Apparel
Applicant	DEPUY, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581-0988 US Other 510(k) Applications for this Company
Contact	CHERYL HASTINGS 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	05/09/1996
Decision Date	08/09/1996
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