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510(k) K193085

PuraDERM Gel by 3-D Matrix, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2020
Date Received
November 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by 3-D Matrix, Inc.

  • K222481 — PuraStat (February 28, 2023)
  • K213552 — PuraStat-RM (April 1, 2022)
  • K210211 — PuraStat-OM (October 8, 2021)
  • K210098 — PuraStat-GI (June 25, 2021)
  • K183015 — PuraSinus (April 12, 2019)
  • K143058 — PuraDerm Gel (February 13, 2015)

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