FDA 510(k) Application Details - K110713

Device Classification Name	Attachment, Breathing, Positive End Expiratory Pressure   More FDA Info for this Device
510(K) Number	K110713
Device Name	Attachment, Breathing, Positive End Expiratory Pressure
Applicant	AIRWAYS DEVELOPMENT, LLC P.O. BOX 558 CEDAR KNOLLS, NJ 07927 US Other 510(k) Applications for this Company
Contact	RICHARD J LARKIN 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	03/15/2011
Decision Date	09/12/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review