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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 K031814
Device Name STATCO2METER, MODEL 10-55372
Applicant
Mercury Medical
11300 49th St. N.
Clearwater,  FL  33762
Applicant Contact WAYNE GLOVER
Correspondent
Mercury Medical
11300 49th St. N.
Clearwater,  FL  33762
Correspondent Contact WAYNE GLOVER
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
CAP  
Date Received06/12/2003
Decision Date 08/14/2003
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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