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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 K030418
Device Name MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
Applicant
Makai Marine Industries, Inc.
P.O. Box 272039
Boca Raton,  FL  33427
Applicant Contact MARC R KAISER
Correspondent
Makai Marine Industries, Inc.
P.O. Box 272039
Boca Raton,  FL  33427
Correspondent Contact MARC R KAISER
Regulation Number868.5470
Classification Product Code
CBF  
Date Received02/10/2003
Decision Date 01/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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