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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Control Unit, Cardiopulmonary Bypass
510(k) Number K023745
Device Name SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
Applicant
Sechrist Industries, Inc.
4225 E. La Palma
Anaheim,  CA  92807
Applicant Contact GREG GODFREY
Correspondent
Sechrist Industries, Inc.
4225 E. La Palma
Anaheim,  CA  92807
Correspondent Contact GREG GODFREY
Regulation Number870.4300
Classification Product Code
DTX  
Date Received11/07/2002
Decision Date 01/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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