FDA 510(k) Application Details - K000654

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K000654
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	A-M SYSTEMS, INC. 131 BUSINESS PARK LOOP P.O. BOX 850 CARLSBORG, WA 98324 US Other 510(k) Applications for this Company
Contact	STEVE GRASSER 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	02/28/2000
Decision Date	11/14/2000
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