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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 K020974
Device Name BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
Applicant
Environmental Tectonics Corp.
125 James Way
Southampton,  PA  18966
Applicant Contact MICHAEL W ALLEN
Correspondent
Environmental Tectonics Corp.
125 James Way
Southampton,  PA  18966
Correspondent Contact MICHAEL W ALLEN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received03/26/2002
Decision Date 06/26/2002
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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