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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 K072427
Device Name SIGMA SERIES HYPERBARIC CHAMBER
Applicant
PERRY BAROMEDICAL CORP.
3660 INTERSTATE PKWY.
RIVIERA BEACH,  FL  33404
Applicant Contact JOHN CROCKER
Correspondent
PERRY BAROMEDICAL CORP.
3660 INTERSTATE PKWY.
RIVIERA BEACH,  FL  33404
Correspondent Contact JOHN CROCKER
Regulation Number868.5470
Classification Product Code
CBF  
Date Received08/29/2007
Decision Date 06/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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