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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 K782152
Device Name VALVE, AMBU PEEP
Applicant
NARCO AIR-SHIELDS
Houston,  TN  77061
Applicant Contact unknown unknown
Correspondent
NARCO AIR-SHIELDS
Houston,  TX  77061
Correspondent Contact unknown unknown
Regulation Number868.5965
Classification Product Code
BYE  
Date Received12/26/1978
Decision Date 12/26/1978
Decision SE - Postmarket Surveillance Required (SESP)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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