K232223
- 510(k) number
- K232223
- Device name
- PlaDuo System
- Applicant
- ShenB Co., Ltd. KR
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2023-10-24
- Date received
- 2023-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232223.pdf
Official FDA record: K232223
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.