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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 K935311
Device Name CLINICAL BLOOD GAS
Applicant
ACETYLENE GAS CO.
3500 BERNARD
ST. LOUIS,  MO  63103
Applicant Contact KRIS LUTHER
Correspondent
ACETYLENE GAS CO.
3500 BERNARD
ST. LOUIS,  MO  63103
Correspondent Contact KRIS LUTHER
Regulation Number868.6400
Classification Product Code
BXK  
Date Received11/02/1993
Decision Date 12/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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