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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 K950957
Device Name MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM
Applicant
Gulf Coast Hyperbarics, Inc.
4309 Green Leaf Circle
Panama City,  FL  32404
Applicant Contact JAMES W MCCARTHY
Correspondent
Gulf Coast Hyperbarics, Inc.
4309 Green Leaf Circle
Panama City,  FL  32404
Correspondent Contact JAMES W MCCARTHY
Regulation Number868.5470
Classification Product Code
CBF  
Date Received03/02/1995
Decision Date 06/02/1995
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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