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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, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
510(k) Number K122794
Device Name UPSYLON Y MESH
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact LAUREN ANDERSON
Correspondent
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact LAUREN ANDERSON
Regulation Number878.3300
Classification Product Code
OTO  
Date Received09/12/2012
Decision Date 12/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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