FDA 510(k) Application Details - K173258

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K173258
Device Name	Surgeon'S Gloves
Applicant	Pt. Medisafe Technologies J1 Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar, Kecamatan Tanjung Morawa Medan 20362 ID Other 510(k) Applications for this Company
Contact	Deepak Bang 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	10/10/2017
Decision Date	04/20/2018
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