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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 K072757
Device Name DIVE AND SHALLOW AND GRAND DIVE
Applicant
Summit TO Sea
1744 Avocet Lane
Mound,  MN  55364
Applicant Contact BRUCE MCKEEMAN
Correspondent
Summit TO Sea
1744 Avocet Lane
Mound,  MN  55364
Correspondent Contact BRUCE MCKEEMAN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received09/27/2007
Decision Date 02/08/2008
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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