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510(k) K240510

Microdacyn Hydrogel by Sonoma Pharmaceuticals, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2024
Date Received
February 22, 2024
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 Sonoma Pharmaceuticals, Inc.

  • K233399 — Microdacyn Wound Care Solution (September 13, 2024)
  • K173896 — Microcyn Antimicrobial Hydrogel (April 2, 2018)
  • K171935 — Alevicyn SG Antimicrobial Gel (December 1, 2017)
  • K172622 — Microcyn Antimicrobial Skin and Wound Cleanser (November 21, 2017)
  • K172851 — Microcyn Plus Antimicrobial Wound Care Solution (November 15, 2017)
  • K171727 — Hydrocleanse Antimicrobial Skin and Wound Care Solution (July 26, 2017)

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