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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 K952545
Device Name WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
Applicant
Wright Industries
13760 S. Gramercy Pl.
Gardena,  CA  90249
Applicant Contact CHARLES WRIGHT
Correspondent
Wright Industries
13760 S. Gramercy Pl.
Gardena,  CA  90249
Correspondent Contact CHARLES WRIGHT
Regulation Number868.5470
Classification Product Code
CBF  
Date Received06/02/1995
Decision Date 05/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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