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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 K951805
Device Name PIPER, MODEL NUMBER UDS-PIPERB
Applicant
Laborie Medical Technologies, Ltd.
6415 Northwest Dr., Unit 11
Mississauga,  CA L4V 1X1
Applicant Contact FRED BUFFA
Correspondent
Laborie Medical Technologies, Ltd.
6415 Northwest Dr., Unit 11
Mississauga,  CA L4V 1X1
Correspondent Contact FRED BUFFA
Regulation Number876.1620
Classification Product Code
FEN  
Date Received04/18/1995
Decision Date 07/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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