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510(k) DEN160012

D2 Dressing by Z-Medica, LLC — Product Code POD

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: June 30, 2017
Date Received: March 16, 2016
Clearance Type: Direct
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