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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 K770766
Device Name REGULATOR, PRESSURE, EXPIRATORY
Original Applicant
GLOBE SAFETY PRODUCTS, INC.
Regulation Number868.5965
Classification Product Code
BYE  
Date Received04/28/1977
Decision Date 05/10/1977
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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