Clearance Summary
ACCU-LINE SURGICAL MARKER received FDA 510(k) clearance under submission number K830298, sponsored by Accu-Line. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1983-06-02.
- Submission: K830298
- Applicant / Sponsor: Accu-Line
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4660
- Decision date: 1983-06-02
Classification & Regulation
This clearance is catalogued under FDA product code FZZ and 21 CFR 878.4660, within the General, Plastic Surgery review panel as a Class I device.