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510(k) K062750

WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 by Boston Scientific Corp — Product Code MUM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2006
Date Received
September 14, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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