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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 WEST 26TH ST.
LYNN HAVEN,  FL  32444
Applicant Contact JAMES W MCCARTHY
Correspondent
GULF COAST HYPERBARICS, INC.
1100 WEST 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
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