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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 K001409
Device Name GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
Applicant
Hyperbaric Technologies, Inc.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Applicant Contact PAUL E DRYDEN
Correspondent
Hyperbaric Technologies, Inc.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received05/04/2000
Decision Date 08/02/2000
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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