Clearance Summary
EXTENSION DEVICE 1416 received FDA 510(k) clearance under submission number K873276, sponsored by Stierlen-Maquet AG. 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 1987-09-17.
- Submission: K873276
- Applicant / Sponsor: Stierlen-Maquet AG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1987-09-17
Classification & Regulation
This clearance is catalogued under FDA product code JEB and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.