FDA 510(k) Application Details - K081266

Device Classification Name	Attachment, Breathing, Positive End Expiratory Pressure   More FDA Info for this Device
510(K) Number	K081266
Device Name	Attachment, Breathing, Positive End Expiratory Pressure
Applicant	MERCURY ENTERPRIZES DBA MERCURY MEDICAL 11300 49TH STREET NORTH CLEARWATER, FL 33762 US Other 510(k) Applications for this Company
Contact	BRIAN L MORRISON Other 510(k) Applications for this Contact
Regulation Number	868.5965   More FDA Info for this Regulation Number
Classification Product Code	BYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2008
Decision Date	03/05/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review