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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(K) Number K020110
Device Name MODIFICATION TO TRELEX MESH SURGICAL MESH
Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick,  MA  01760
Contact lorraine m hanley
Regulation Number878.3300
Classification Product Code
FTL  
Date Received01/11/2002
Decision Date 04/03/2002
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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