FDA 510(k) Application Details - K001343

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K001343
Device Name	Surgeon'S Gloves
Applicant	MAXXIM MEDICAL, INC. 308 CHURCH ST. HONE PATH, SC 29654 US Other 510(k) Applications for this Company
Contact	PALLIE STODDARD 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	04/27/2000
Decision Date	06/12/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review