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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 K964522
Device Name ELLIPSE 4
Applicant
ANDROMEDA MEDIZINISCHE SYSTEME GMBH
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Applicant Contact NORMAN F ESTRIN, PH.D. , RAC
Correspondent
ANDROMEDA MEDIZINISCHE SYSTEME GMBH
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Correspondent Contact NORMAN F ESTRIN, PH.D. , RAC
Regulation Number876.1620
Classification Product Code
FEN  
Subsequent Product Code
EXY  
Date Received11/12/1996
Decision Date 03/21/1997
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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