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510(k) K060323

ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 by Boston Scientific Corporation — Product Code MQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2006
Date Received
February 9, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Colonic, Metallic, Expandable
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type

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  • K113510 — EVOLUTION COLONIC STENT SYSTEM (May 17, 2012)
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