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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 K993010
Device Name BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
Applicant
Environmental Tectonics Corp.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Environmental Tectonics Corp.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received09/07/1999
Decision Date 05/30/2000
Decision Substantially Equivalent (SESE)
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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