FDA 510(k) Application Details - K153498

Device Classification Name	More FDA Info for this Device
510(K) Number	K153498
Device Name	Operio
Applicant	TOUL MEDITECH AB TUNBYTORPSGATAN 31 VΣsterσs 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	12/07/2015
Decision Date	07/20/2016
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