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FDA 510(k) Application Details - K080185
Device Classification Name
More FDA Info for this Device
510(K) Number
K080185
Device Name
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
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Contact
MONA INMAN
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OTP
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More FDA Info for this Product Code
Date Received
01/25/2008
Decision Date
04/10/2008
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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