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510(k) K991056

WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM by Boston Scientific Corp — Product Code MQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1999
Date Received
March 30, 1999
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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  • K180180 — HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NN (November 2, 2018)
  • K113510 — EVOLUTION COLONIC STENT SYSTEM (May 17, 2012)
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  • K060323 — ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 (May 12, 2006)
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