510(k) K030769

ULTRAFLEX PRECISION COLONIC STENT by Boston Scientific Corp — Product Code MQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2003
Date Received
March 11, 2003
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