FDA 510(k) Application Details - K012819

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K012819
Device Name	Surgeon'S Gloves
Applicant	SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT 1308 MORNINGSTAR PARK DR. APHARETTA, GA 30022 US Other 510(k) Applications for this Company
Contact	JAY MANSOUR 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	08/23/2001
Decision Date	11/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review