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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 K082455
Device Name RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
Applicant
Gulf Coast Hyperbarics, Inc.
1100 W. 26th St.
Lynn Haven,  FL  32444
Applicant Contact JAMES W MCCARTHY
Correspondent
Gulf Coast Hyperbarics, Inc.
1100 W. 26th St.
Lynn Haven,  FL  32444
Correspondent Contact JAMES W MCCARTHY
Regulation Number868.5470
Classification Product Code
CBF  
Date Received08/26/2008
Decision Date 05/22/2009
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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