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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 K874107
Device Name H.T.U. (HYPERBARIC THERAPY UNIT)
Applicant
Hyox Systems C/O Mechidyne Systems, Inc.
P.O. Box 19838
Houston,  TX  77224
Applicant Contact AUDLEY L AARON
Correspondent
Hyox Systems C/O Mechidyne Systems, Inc.
P.O. Box 19838
Houston,  TX  77224
Correspondent Contact AUDLEY L AARON
Regulation Number868.5470
Classification Product Code
CBF  
Date Received10/09/1987
Decision Date 12/07/1987
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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