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510(k) K192413

SiteSeal Femoral Compression Device by Ensite Vacular, LLC — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2020
Date Received
September 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

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