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FDA 510(k) Application Details - K073703
Device Classification Name
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510(K) Number
K073703
Device Name
AMS MINIARC SLING SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
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BRAD ONSTAD
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Regulation Number
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Classification Product Code
PAH
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Date Received
12/31/2007
Decision Date
01/30/2008
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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