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510(k) K073251

HYALOMATRIX PA by Fidia Advanced Biopolymers Srl — Product Code QSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2007
Date Received
November 19, 2007
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 Fidia Advanced Biopolymers Srl

  • K092257 — JALOSKIN (January 26, 2010)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K003855 — HYALOMATRIX CO (July 3, 2001)

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  • K232847 — SiOxD Wound Matrix (December 18, 2023)
  • K223725 — Restrata® MiniMatrix (May 18, 2023)
  • K222189 — SiOxD Wound Matrix (November 18, 2022)
  • K221686 — NovoSorb Matrix (September 15, 2022)
  • 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)