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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 K936041
Device Name UROGRAM CYSTOMETROGRAM
Applicant
MYO/KINETIC SYSTEMS, INC.
N84 W13562 LEON RD.
MENOMONEE FALLS,  WI  53051
Applicant Contact HASSAN HAMEDI
Correspondent
MYO/KINETIC SYSTEMS, INC.
N84 W13562 LEON RD.
MENOMONEE FALLS,  WI  53051
Correspondent Contact HASSAN HAMEDI
Regulation Number876.1620
Classification Product Code
FEN  
Date Received12/20/1993
Decision Date 04/18/1994
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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