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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas, Calibration (Specified Concentration)
510(k) Number K953208
Device Name MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES
Applicant
Standard Welders Supply Co.
1259 N. Mclean
Memphis,  TN  38108
Applicant Contact CHARLES W BRITTON
Correspondent
Standard Welders Supply Co.
1259 N. Mclean
Memphis,  TN  38108
Correspondent Contact CHARLES W BRITTON
Regulation Number868.6400
Classification Product Code
BXK  
Date Received06/19/1995
Decision Date 07/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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