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FDA 510(k) Application Details - K023516
Device Classification Name
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510(K) Number
K023516
Device Name
MONARC SLING SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
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Contact
David Worrell
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Regulation Number
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Classification Product Code
OTN
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Date Received
10/21/2002
Decision Date
11/19/2002
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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