Clearance Summary
DPA 207 PERSONAL received FDA 510(k) clearance under submission number K802513, sponsored by Hill, Farrer & Borrill. 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 1980-12-16.
- Submission: K802513
- Applicant / Sponsor: Hill, Farrer & Borrill
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5360
- Decision date: 1980-12-16
Classification & Regulation
This clearance is catalogued under FDA product code KCX and 21 CFR 878.5360, within the General, Plastic Surgery review panel as a Class I device.