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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