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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Cystometric, Hydraulic
510(k) Number K942023
Device Name INFUSION PUMP, MODEL NO. UDP-5
Applicant
LABORIE MEDICAL TECHNOLOGIES, LTD.
7 GREEN TREE DR. #4
SOUTH BURLINGTON,  VT  05403
Applicant Contact FRED BUFFA
Correspondent
LABORIE MEDICAL TECHNOLOGIES, LTD.
7 GREEN TREE DR. #4
SOUTH BURLINGTON,  VT  05403
Correspondent Contact FRED BUFFA
Regulation Number876.1620
Classification Product Code
FEN  
Date Received04/26/1994
Decision Date 07/12/1994
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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