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510(k) K161020

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack by Revmedx, Inc. — Product Code PGZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 28, 2016
Date Received: April 12, 2016
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Device Class: Class II
Regulation Number: 878.4452
Review Panel: SU
Submission Type

To control bleeding in junctional, non-compressible wounds until surgical care is acquired.