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510(k) K180102

Embozene Color-Advanced Microspheres by Boston Scientific — Product Code NOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2018
Date Received
January 16, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Device Class
Class II
Regulation Number
876.5550
Review Panel
GU
Submission Type

The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).

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