FDA 510(k) Application Details - K201765

Device Classification Name Meter, Conductivity, Non-Remote

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510(K) Number K201765
Device Name Meter, Conductivity, Non-Remote
Applicant Mesa Laboratories, Inc.
12100 West 6th Ave.
Lakewood, CO 80228 US
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Contact Jamie Louie
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Regulation Number 876.5820

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Classification Product Code FIZ
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Date Received 06/29/2020
Decision Date 09/02/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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