FDA 510(k) Application Details - K023515

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K023515
Device Name	Surgeon'S Gloves
Applicant	SANREA HEALTHCARE PRIVATE LIMITED COCHIN SPECIAL ECONOMIC ZONE KAKKANAD, COCHIN KERALA 682037 IN Other 510(k) Applications for this Company
Contact	JOSE PAUL M 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	10/21/2002
Decision Date	01/16/2003
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