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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 K073552
Device Name LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
Applicant
LABORIE MEDICAL TECHNOLOGIES, CORP
400 AVE D, STE 10
WILLISTON,  VT  05495
Applicant Contact BARBARA MORNET
Correspondent
LABORIE MEDICAL TECHNOLOGIES, CORP
400 AVE D, STE 10
WILLISTON,  VT  05495
Correspondent Contact BARBARA MORNET
Regulation Number876.1620
Classification Product Code
FEN  
Subsequent Product Code
EXQ  
Date Received12/18/2007
Decision Date 03/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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