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510(k) K183190

NuStat by Beeken Biomedical, LLC — Product Code POD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 25, 2019
Date Received: November 19, 2018
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