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510(k) K160643

ENROUTE 0.014 Guidewire by Lake Region Medical — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2016
Date Received
March 7, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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