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FDA 510(k) Application Details - K082677
Device Classification Name
More FDA Info for this Device
510(K) Number
K082677
Device Name
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
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Contact
MONA INMAN
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Regulation Number
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Classification Product Code
OTP
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Date Received
09/15/2008
Decision Date
12/23/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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