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510(k) K200167

QuikClot Control+ by Z-Medica, LLC — Product Code POD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 23, 2020
Date Received: January 23, 2020
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Temporary, Internal Use Hemostatic
Device Class: Class II
Regulation Number: 878.4454
Review Panel: SU
Submission Type

Intended to control severely bleeding wounds