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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K874752
Device Name GAMOW HYPERBARIC BAG
Applicant
Hyperbaric Aerobics, Ltd.
P.O. Box 17696
Boulder,  CO  80308
Applicant Contact IGOR GAMOW
Correspondent
Hyperbaric Aerobics, Ltd.
P.O. Box 17696
Boulder,  CO  80308
Correspondent Contact IGOR GAMOW
Regulation Number868.5470
Classification Product Code
CBF  
Date Received11/18/1987
Decision Date 02/02/1988
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
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