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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K935044
Device Name EASYFLOW AIRWAY ADAPTER
Applicant
Easyflow Airway Systems, Inc.
P.O. Box 2010
Palm Florida,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
Easyflow Airway Systems, Inc.
P.O. Box 2010
Palm Florida,  FL  34682
Correspondent Contact PATRICK J LAMB
Regulation Number868.5240
Classification Product Code
CAI  
Date Received10/20/1993
Decision Date 11/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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