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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 K974868
Device Name SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
Applicant
PERRY BAROMEDICAL CORP.
7555 GARDEN RD.
RIVIERA BEACH,  FL  33404
Applicant Contact JAMES P DODSON
Correspondent
PERRY BAROMEDICAL CORP.
7555 GARDEN RD.
RIVIERA BEACH,  FL  33404
Correspondent Contact JAMES P DODSON
Regulation Number868.5470
Classification Product Code
CBF  
Date Received12/29/1997
Decision Date 07/02/1998
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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