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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, hemodialysis, access recirculation monitoring
510(k) Number K001763
Device Name CRIT-LINE MONITOR III (CLM III)
Applicant
IN-LINE DIAGNOSTICS CORP.
695 NORTH, 900 WEST
KAYSVILLE,  UT  84037
Applicant Contact MATTHEW L HAYNIE
Correspondent
IN-LINE DIAGNOSTICS CORP.
695 NORTH, 900 WEST
KAYSVILLE,  UT  84037
Correspondent Contact MATTHEW L HAYNIE
Regulation Number876.5820
Classification Product Code
MQS  
Date Received06/12/2000
Decision Date 12/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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