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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, penile
510(k) Number K955810
Device Name U-TEX
Applicant
LABORIE MEDICAL TECHNOLOGIES, LTD.
6415 NORTHWEST DR.
UNIT 11
MISSISSAUGA (ONTARIO),  CA L4V 1X1
Applicant Contact FRED BUFFA
Correspondent
LABORIE MEDICAL TECHNOLOGIES, LTD.
6415 NORTHWEST DR.
UNIT 11
MISSISSAUGA (ONTARIO),  CA L4V 1X1
Correspondent Contact FRED BUFFA
Regulation Number876.5160
Classification Product Code
FHA  
Date Received12/26/1995
Decision Date 01/24/1996
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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