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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agents, Embolic, For Treatment Of Uterine Fibroids
510(k) Number K100663
Device Name CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
Applicant
Boston Scientific Corporation
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Applicant Contact DEBBIE MCINTIRE
Correspondent
Boston Scientific Corporation
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Correspondent Contact DEBBIE MCINTIRE
Regulation Number870.3300
Classification Product Code
NAJ  
Date Received03/08/2010
Decision Date 04/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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