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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name circuit, breathing (w connector, adaptor, y piece)
510(k) Number K792499
Device Name AMBU PAEDI ANAESTHESIA SYSTEM
Applicant
NARCO AIR-SHIELDS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NARCO AIR-SHIELDS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5240
Classification Product Code
CAI  
Date Received12/04/1979
Decision Date 12/19/1979
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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