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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K050066
Device Name C-CO2 COLORIMETRIC CO2 INDICATOR
Applicant
Marquest Medical Products, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Applicant Contact THOMAS W DIELMANN
Correspondent
Marquest Medical Products, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Correspondent Contact THOMAS W DIELMANN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received01/12/2005
Decision Date 03/01/2005
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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