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510(k) K153264

EasyPass Guidewire by Medi-Globe Corporation — Product Code OCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2016
Date Received
November 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Guidewire, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

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