FDA.report

510(k) K211943

Device
Microlyte Ag/Lidocaine
Applicant
Imbed Biosciences
510(k) number
K211943
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-17
Date received
2021-06-23
Classification name
Dressing, Wound, Drug
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Ankit Agarwal
Address
5520 Nobel Dr., Suite 100 Fitchburg WI US 53711 53711

FDA Registration Numbers

Source Documents

510(k) summary PDF

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