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FDA 510(k) Application Details - K040538
Device Classification Name
More FDA Info for this Device
510(K) Number
K040538
Device Name
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
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Contact
DENISE THOMPSON
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Regulation Number
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Classification Product Code
OTN
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Date Received
03/02/2004
Decision Date
03/17/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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