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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, dialysate delivery, single pass
510(k) Number K011741
FOIA Releasable 510(k) K011741
Device Name CRIT-LINE MONITOR III TQA (CLM TQA)
Applicant
HEMAMETRICS
695 NORTH, 900 WEST
KAYSVILLE,  UT  84037
Applicant Contact MATTHEW L HAYNIE
Correspondent
HEMAMETRICS
695 NORTH, 900 WEST
KAYSVILLE,  UT  84037
Correspondent Contact MATTHEW L HAYNIE
Regulation Number876.5820
Classification Product Code
FIL  
Subsequent Product Code
MQS  
Date Received06/05/2001
Decision Date 07/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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