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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K843835
Device Name OHMEDA PEEP VALVE FOR GMS ABSORBER
Applicant
Ohmeda Medical
P.O. Box 7550
Madison,  WI  53707
Applicant Contact RAYMOND T RIDDLE
Correspondent
Ohmeda Medical
P.O. Box 7550
Madison,  WI  53707
Correspondent Contact RAYMOND T RIDDLE
Regulation Number868.5965
Classification Product Code
BYE  
Date Received10/01/1984
Decision Date 11/15/1984
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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