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510(k) K031684

TOPKIN WOUND DRESSING by Biomet Merck GmbH — Product Code QSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2003
Date Received
May 30, 2003
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 for product code QSZ

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  • K222189 — SiOxD Wound Matrix (November 18, 2022)
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  • K193583 — Restrata® (September 25, 2020)
  • K173544 — Phoenix Wound Matrix (March 2, 2018)
  • K172140 — NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10c (August 11, 2017)