FDA 510(k) Application Details - K021992

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K021992
Device Name	Gown, Surgical
Applicant	BIOMET, INC. P.O. BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	KACY ARNOLD 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	06/18/2002
Decision Date	01/14/2003
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