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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 K953734
Device Name LUMAX(MODIFICATION)
Applicant
MEDAMICUS, INC.
15301 HWY. 55 WEST
MINNEAPOLIS,  MN  55447
Applicant Contact DENNIS MADISON
Correspondent
MEDAMICUS, INC.
15301 HWY. 55 WEST
MINNEAPOLIS,  MN  55447
Correspondent Contact DENNIS MADISON
Regulation Number876.1620
Classification Product Code
FEN  
Date Received07/17/1995
Decision Date 01/18/1996
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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