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510(k) K120983

ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM by Boston Scientific Corporation — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2012
Date Received
April 2, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Esophageal
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type

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