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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 K900291
Device Name MASS SPECTROMETRY MONITORING LINES AND CONNECTORS
Applicant
F.L.W. Plastics, Inc.
4920 N. Warren Dr.
Columbus,  IN  47203
Applicant Contact TIMOTHY D STRUTHERS
Correspondent
F.L.W. Plastics, Inc.
4920 N. Warren Dr.
Columbus,  IN  47203
Correspondent Contact TIMOTHY D STRUTHERS
Regulation Number868.1400
Classification Product Code
CCK  
Date Received01/22/1990
Decision Date 03/28/1990
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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