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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 K802943
Device Name POSITIVE END EXPIRATORY PRESSURE VALVE
Applicant
FRASER HARLAKE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FRASER HARLAKE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5965
Classification Product Code
BYE  
Date Received11/19/1980
Decision Date 01/15/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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