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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 K971911
Device Name LUMAX CYSTOMETRY ADMINISTRATION TUBE SET
Applicant
Medamicus, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Applicant Contact DENNIS S MADISON
Correspondent
Medamicus, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Correspondent Contact DENNIS S MADISON
Regulation Number876.1620
Classification Product Code
FEN  
Date Received04/28/1997
Decision Date 06/03/1997
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
Predetermined Change
Control Plan Authorized		 No
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