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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cystometric gas (carbon-dioxide) on hydraulic device
510(k) Number K913169
Device Name DANTEC UD 5500 MK2
Applicant
DANTEC MEDICAL, INC.
1575 EYE STREET, N.W.
WASHINGTON,  DC  20005
Applicant Contact RICHARD D MANTHEI
Correspondent
DANTEC MEDICAL, INC.
1575 EYE STREET, N.W.
WASHINGTON,  DC  20005
Correspondent Contact RICHARD D MANTHEI
Regulation Number876.1620
Classification Product Code
FAP  
Date Received07/17/1991
Decision Date 01/23/1992
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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