FDA 510(k) Application Details - K162362

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K162362
Device Name	Wrap, Sterilization
Applicant	PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS KARADUVAR MAH.SERBEST BOLGE, 11.CAD NO.46 MERSIN SERBEST BOLGESI, AKDENIZ MERSIN 33020 TR Other 510(k) Applications for this Company
Contact	DERYA DIKICI Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2016
Decision Date	10/13/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review