FDA.report

510(k) K240510

Device
Microdacyn Hydrogel
Applicant
Sonoma Pharmaceuticals, Inc.
510(k) number
K240510
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-08
Date received
2024-02-22
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
Everardo Garibay Ramirez
Address
1129 N. Mcdowell Blvd. Petaluma CA US 94954 94954

FDA Registration Numbers

Source Documents

510(k) summary PDF

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