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FDA 510(k) Application Details - K090934
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K090934
Device Name
Mesh, Surgical, Polymeric
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
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Contact
SARAH MEYER
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
FTL
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More FDA Info for this Product Code
Date Received
04/02/2009
Decision Date
06/02/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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