Clearance Summary
TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 received FDA 510(k) clearance under submission number K031225, sponsored by Gfe Medizintechnik GmbH. 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 2003-09-29.
- Submission: K031225
- Applicant / Sponsor: Gfe Medizintechnik GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2003-09-29
Classification & Regulation
This clearance is catalogued under FDA product code FTL and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.