Clearance Summary
RAKA OCH BOSDA PEANGER received FDA 510(k) clearance under submission number K851673, sponsored by General Electric Trading Co.. 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 1985-05-29.
- Submission: K851673
- Applicant / Sponsor: General Electric Trading Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1985-05-29
Classification & Regulation
This clearance is catalogued under FDA product code GEN and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.