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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 K990927
Device Name SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
Applicant
PERRY BAROMEDICAL CORP.
3660 INTERSTATE PKWY.
RIVERA BEACH,  FL  33404
Applicant Contact JAMES P DODSON
Correspondent
PERRY BAROMEDICAL CORP.
3660 INTERSTATE PKWY.
RIVERA BEACH,  FL  33404
Correspondent Contact JAMES P DODSON
Regulation Number868.5470
Classification Product Code
CBF  
Date Received03/19/1999
Decision Date 11/12/1999
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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