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510(k) K182985

Roadrunner PC Wire Guide, Olcott Torque Device by Cook Incorporated — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2019
Date Received
October 29, 2018
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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