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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 K790693
Device Name HYPERBARIC OXYGEN CHAMBER
Original Applicant
HYPERBARIC OXYGEN THERAPY, INC.
Regulation Number868.5470
Classification Product Code
CBF  
Date Received04/10/1979
Decision Date 07/30/1979
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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