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FDA 510(k) Application Details - K033671
Device Classification Name
More FDA Info for this Device
510(K) Number
K033671
Device Name
GORE BIOABSORBABLE MESH
Applicant
W. L. GORE & ASSOCIATES, INC.
3450 WEST KILTIE LN.
FLAGSTAFF, AZ 86001 US
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Contact
BRANDON HANSEN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/24/2003
Decision Date
12/31/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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