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510(k) K170213

SupraSDRM Biodegradable Matrix Wound Dressing by Polymedics Innovations, GmbH — Product Code QSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2017
Date Received
January 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorbable Synthetic Wound Dressing
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.

Other clearances by Polymedics Innovations, GmbH

  • K090160 — SUPRATHEL WOUND AND BURN DRESSING (May 20, 2009)

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