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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 K911737
Device Name MEDICAL ASSEMBLIES MASS SPECT MONIT LINE/CONNECT
Applicant
Medical Assemblies, Inc.
2002 W. Vernal Pike
Bloomington,  IN  47404
Applicant Contact GREG POPP
Correspondent
Medical Assemblies, Inc.
2002 W. Vernal Pike
Bloomington,  IN  47404
Correspondent Contact GREG POPP
Regulation Number868.1400
Classification Product Code
CCK  
Date Received04/17/1991
Decision Date 07/11/1991
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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