FDA 510(k) Application Details - K964382

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K964382
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 INDIANAPOLIS, IN 46236 US Other 510(k) Applications for this Company
Contact	CHYRELL SAUNDERS 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	11/04/1996
Decision Date	04/15/1997
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