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FDA 510(k) Application Details - K051485
Device Classification Name
More FDA Info for this Device
510(K) Number
K051485
Device Name
AMS PELVIC FLOOR REPAIR SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
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Contact
ELSA LINKE
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Regulation Number
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Classification Product Code
OTO
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Date Received
06/06/2005
Decision Date
08/03/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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