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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meter, conductivity, non-remote
510(k) Number K150657
Device Name Phoenix XL Dialysate Meter
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
FIZ  
Date Received03/13/2015
Decision Date 09/21/2015
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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