Clearance Summary
FINALLY FREE received FDA 510(k) clearance under submission number K972695, sponsored by Mehl/Group Marketing. 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 1997-10-22.
- Submission: K972695
- Applicant / Sponsor: Mehl/Group Marketing
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5360
- Decision date: 1997-10-22
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.