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FDA 510(k) Application Details - K082387
Device Classification Name
More FDA Info for this Device
510(K) Number
K082387
Device Name
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS
10700 BREN ROAD WEST
MINNETONKA, MN 55416 US
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Contact
SARAH PETERSON
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Regulation Number
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Classification Product Code
OTP
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Date Received
08/19/2008
Decision Date
12/04/2008
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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