Rejuvapen NXT— 510(k) K192138
Substantially EquivalentRefine USA, LLC
FDA 510(k) clearance K192138 for Rejuvapen NXT, Substantially Equivalent on 2020-04-09. Applicant: Refine USA, LLC. Device class: 2.
Clearance details
- Applicant
- Refine USA, LLC
- Product code
- Code QAI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4430
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville Beach, FL, US
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