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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 K130100
Device Name COMINED STANDARD SOLUTION
Applicant
MESA LABORATORIES, INC.
12100 W 6th Ave
LAKEWOOD,  CO  80228
Applicant Contact JAMIE LOUIE
Correspondent
MESA LABORATORIES, INC.
12100 W 6th Ave
LAKEWOOD,  CO  80228
Correspondent Contact JAMIE LOUIE
Regulation Number876.5820
Classification Product Code
FKH  
Date Received01/15/2013
Decision Date 04/18/2013
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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