Clearance Summary
DUET received FDA 510(k) clearance under submission number K934970, sponsored by Trulife , 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 1993-12-10.
- Submission: K934970
- Applicant / Sponsor: Trulife , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.3750
- Decision date: 1993-12-10
Classification & Regulation
This clearance is catalogued under FDA product code GBJ and 21 CFR 878.3750, within the General, Plastic Surgery review panel as a Class I device.