Clearance Summary
PEN, MARK-3 SKIN MARKING FOUNTAIN received FDA 510(k) clearance under submission number K781694, sponsored by Omega Mark-3 Pen Corp.. 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 1978-12-04.
- Submission: K781694
- Applicant / Sponsor: Omega Mark-3 Pen Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4660
- Decision date: 1978-12-04
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.