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510(k) K211943

Microlyte Ag/Lidocaine by Imbed Biosciences — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2024
Date Received
June 23, 2021
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 Imbed Biosciences

  • K153756 — Microlyte Ag (August 4, 2016)

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