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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 K960389
Device Name HYPERBARIC CHAMBER
Applicant
TAMPA HYPERBARIC ENT.
700 WEST WATERS AVE.
TAMPA,  FL  33604
Applicant Contact MICHAEL CAPRIA
Correspondent
TAMPA HYPERBARIC ENT.
700 WEST WATERS AVE.
TAMPA,  FL  33604
Correspondent Contact MICHAEL CAPRIA
Regulation Number868.5470
Classification Product Code
CBF  
Date Received01/22/1996
Decision Date 12/05/1996
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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