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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solution-test standard-conductivity, dialysis
510(k) Number K033330
Device Name CONDUCTIVITY/TDS CALIBRATOR SOLUTION
Applicant
MESA LABORATORIES, INC.
12100 WEST 6TH AVE.
LAKEWOOD,  CO  80228
Applicant Contact TODD ROMERO
Correspondent
MESA LABORATORIES, INC.
12100 WEST 6TH AVE.
LAKEWOOD,  CO  80228
Correspondent Contact TODD ROMERO
Regulation Number876.5820
Classification Product Code
FKH  
Date Received10/16/2003
Decision Date 02/27/2004
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
Recalls CDRH Recalls
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