FDA 510(k) Application Details - K112654

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K112654
Device Name	Surgeon'S Gloves
Applicant	PT. MEDISAFE TECHNOLOGIES JL.BATANG KUIS GG.TAMBAK REJO DESA BUNTU BEDIMBAR TJ. MORAWA MEDAN, NORTH SUMATERA 20362 ID Other 510(k) Applications for this Company
Contact	ANIL TANEJA 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	09/12/2011
Decision Date	02/17/2012
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