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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 K952838
Device Name MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES
Applicant
Standard Welders Supply Co.
1259 N. Mclean
Memphis,  TN  38108
Applicant Contact CHUCK BRITTON
Correspondent
Standard Welders Supply Co.
1259 N. Mclean
Memphis,  TN  38108
Correspondent Contact CHUCK BRITTON
Regulation Number868.6400
Classification Product Code
BXK  
Date Received06/19/1995
Decision Date 09/19/1995
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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