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510(k) K152624

XSTAT 30, 3-PACK, XSTAT 30, 1-PACK by Revmedx, Inc. — Product Code PGZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 7, 2015
Date Received: September 14, 2015
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.