Avologi Gel Primer (Model: Av25)
FDA 510(k) K220735 · Premier North America, Inc.
510(k) numberK220735
Submission
- Device name
- Avologi Gel Primer (Model: Av25)
- Applicant
- Premier North America, Inc.
Fort Lauderdale, FL, US - Received
- March 14, 2022
- Decision date
- September 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Avologi Gel Primer (Model: Av25) cleared by the FDA?
Avologi Gel Primer (Model: Av25) (K220735) received a 510(k) decision of Substantially Equivalent on September 15, 2023, 550 days after the submission was received.
What is the product code of K220735?
The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.