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510(k) K100663

CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 by Boston Scientific Corporation — Product Code NAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2010
Date Received
March 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class
Class II
Regulation Number
870.3300
Review Panel
OB
Submission Type

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