FDA 510(k) Application Details - K101629

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K101629
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	GLENN MEDICAL SYSTEMS, INC. 511 12TH STREET, N.E. NE CANTON, OH 44704 US Other 510(k) Applications for this Company
Contact	GARY CLEVINGER 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	06/10/2010
Decision Date	07/09/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review