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510(k) K101530

EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D by Cook Ireland, Ltd. — Product Code MUM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2011
Date Received
June 3, 2010
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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Other clearances for product code MUM

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  • K062750 — WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M005650 (December 4, 2006)
  • K980113 — WALLSTENT ENTERAL ENDOPROSTHESIS (April 3, 1998)