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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 K191496
Device Name TDS Standard Solution
Applicant
Mesa Laboratories, Inc.
12100 West 6th Avenue
lakewood,  CO  80228
Applicant Contact jamie louie
Correspondent
Mesa Laboratories, Inc.
12100 West 6th Avenue
lakewood,  CO  80228
Correspondent Contact jamie louie
Regulation Number876.5820
Classification Product Code
FKH  
Date Received06/05/2019
Decision Date 08/05/2019
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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