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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 K923618
Device Name PEEP VALVE
Applicant
International Respiratory Systems, Inc.
386 Broadway
2nd Flr
Newburgh,  NY  12550
Applicant Contact SHEEHAN III
Correspondent
International Respiratory Systems, Inc.
386 Broadway
2nd Flr
Newburgh,  NY  12550
Correspondent Contact SHEEHAN III
Regulation Number868.5965
Classification Product Code
BYE  
Date Received07/21/1992
Decision Date 08/03/1992
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
Recalls CDRH Recalls
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