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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 K002794
Device Name MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
Applicant
Hypertec, Inc.
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Hypertec, Inc.
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number868.5470
Classification Product Code
CBF  
Date Received09/07/2000
Decision Date 12/06/2000
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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