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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 K861398
Device Name PRE-CHECK C02 DETECTOR
Applicant
ALLEGHANY INTL. MEDICAL TECHNOLOGY
897 FEE FEE RD.
ST.LOUIS,  MO  63043
Applicant Contact MICHAEL LOMBARDO
Correspondent
ALLEGHANY INTL. MEDICAL TECHNOLOGY
897 FEE FEE RD.
ST.LOUIS,  MO  63043
Correspondent Contact MICHAEL LOMBARDO
Regulation Number868.1400
Classification Product Code
CCK  
Date Received04/15/1986
Decision Date 05/06/1986
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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