FDA 510(k) Application Details - K132679

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K132679
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	GALEMED CORP. 29201 VIA NORTE TEMECULA, CA 92591 US Other 510(k) Applications for this Company
Contact	TOM SHANKS 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	08/28/2013
Decision Date	04/18/2014
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	N
Expedited Review