Clearance Summary
POTTS-COURNAND STYLE NEEDLE received FDA 510(k) clearance under submission number K813448, sponsored by Ocean Medical Products, Ltd.. 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 1982-01-07.
- Submission: K813448
- Applicant / Sponsor: Ocean Medical Products, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1982-01-07
Classification & Regulation
This clearance is catalogued under FDA product code GAA and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.