FDA 510(k) Application Details - K173349

Device Classification Name	More FDA Info for this Device
510(K) Number	K173349
Device Name	Operio
Applicant	Toul Meditech AB Tunbytorpsgatan 31 Vasteras 72137 SE Other 510(k) Applications for this Company
Contact	Tomas Hansson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2017
Decision Date	12/20/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review