FDA 510(k) Application Details - K964962

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K964962
Device Name	Surgeon'S Gloves
Applicant	MAXXIM MEDICAL 4750 118TH AVENUE NORTH CLEARWATER, FL 33762 US Other 510(k) Applications for this Company
Contact	JOYCE MOODY 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	12/11/1996
Decision Date	03/06/1997
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