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FDA 510(k) Application Details - K131229
Device Classification Name
More FDA Info for this Device
510(K) Number
K131229
Device Name
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
Applicant
AMERICAN MEDICAL SYSTEMS
10700 BREN ROAD WEST
MINNETONKA, MN 55343 US
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Contact
TODD HILDEBRANDT
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Regulation Number
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Classification Product Code
OTN
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More FDA Info for this Product Code
Date Received
04/30/2013
Decision Date
12/05/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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