Avologi Gel Primer (Model: Av25)— 510(k) K220735
Substantially EquivalentPremier North America, Inc.
FDA 510(k) clearance K220735 for Avologi Gel Primer (Model: Av25), Substantially Equivalent on 2023-09-15. Applicant: Premier North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Premier North America, Inc.
- Product code
- Code GYB
- Device class
- Class 2
- Regulation
- 21 CFR 882.1275
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Lauderdale, FL, US
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