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510(k) K182914

MC3 Vascular Access Kit 21030 by Mc3 Incorporated — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2018
Date Received
October 18, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

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