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FDA 510(k) Application Details - K953734
Device Classification Name
Device, Cystometric, Hydraulic
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510(K) Number
K953734
Device Name
Device, Cystometric, Hydraulic
Applicant
MEDAMICUS, INC.
15301 HWY. 55 WEST
MINNEAPOLIS, MN 55447 US
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Contact
DENNIS MADISON
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Regulation Number
876.1620
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Classification Product Code
FEN
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More FDA Info for this Product Code
Date Received
07/17/1995
Decision Date
01/18/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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