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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 K052713
Device Name MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
Applicant
SECHRIST INDUSTRIES, INC.
4225 EAST LA PALMA AVE.
ANAHEIM,  CA  92807
Applicant Contact GREG GODFREY
Correspondent
SECHRIST INDUSTRIES, INC.
4225 EAST LA PALMA AVE.
ANAHEIM,  CA  92807
Correspondent Contact GREG GODFREY
Regulation Number868.5470
Classification Product Code
CBF  
Date Received09/29/2005
Decision Date 10/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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