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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K924086
Device Name NICKI, MODEL NUMBER USD-NK-UP1
Applicant
LABORIE MEDICAL TECHNOLOGIES, LTD.
45 WEST ST.
SUITE 2
ATTLEBORO,  MA  02703
Applicant Contact JAMES R VEALE
Correspondent
LABORIE MEDICAL TECHNOLOGIES, LTD.
45 WEST ST.
SUITE 2
ATTLEBORO,  MA  02703
Correspondent Contact JAMES R VEALE
Regulation Number876.1620
Classification Product Code
FAP  
Date Received08/13/1992
Decision Date 10/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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