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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name uroflowmeter
510(k) Number K941105
Device Name UORCAP,MODEL NUMBER UDS-UCAP
Applicant
LABORIE MEDICAL TECH, INC.
6415 NORTHWEST DR., UNIT 11
MISSISSAUGA, ONTARIO,  CA L4V 1X1
Applicant Contact FRED BUFFA
Correspondent
LABORIE MEDICAL TECH, INC.
6415 NORTHWEST DR., UNIT 11
MISSISSAUGA, ONTARIO,  CA L4V 1X1
Correspondent Contact FRED BUFFA
Regulation Number876.1800
Classification Product Code
EXY  
Date Received03/07/1994
Decision Date 05/10/1994
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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