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FDA 510(k) Application Details - K020110
Device Classification Name
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510(K) Number
K020110
Device Name
MODIFICATION TO TRELEX MESH SURGICAL MESH
Applicant
BOSTON SCIENTIFIC
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact
DONNA M GARDNER
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Regulation Number
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Classification Product Code
OTN
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Date Received
01/11/2002
Decision Date
04/03/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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