FDA 510(k) Application Details - K984064

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K984064
Device Name	Surgeon'S Gloves
Applicant	OMNI INTL., INC. 4916 SPRUCE HILL DR. NW CANTON, OH 44718 US Other 510(k) Applications for this Company
Contact	WILLIAM E PATTON Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/1998
Decision Date	01/08/1999
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