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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 K050812
Device Name 90XL INSTRUMENTATION SYSTEM
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
FIZ  
Date Received03/31/2005
Decision Date 05/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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