FDA 510(k) Application Details - K163300

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K163300
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	Flexicare Medical Limited Cynon Valley Business Park Mountain Ash cf45 4ER GB Other 510(k) Applications for this Company
Contact	Joel Biddle Other 510(k) Applications for this Contact
Regulation Number	868.5260   More FDA Info for this Regulation Number
Classification Product Code	CAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2016
Decision Date	03/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review