Clearance Summary
SCISSORS, SURGICAL, 12.5,14,16 & 18 CM. received FDA 510(k) clearance under submission number K770541, sponsored by Sea-Pac Trading Corp.. 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 1977-04-15.
- Submission: K770541
- Applicant / Sponsor: Sea-Pac Trading Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1977-04-15
Classification & Regulation
This clearance is catalogued under FDA product code FZT and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.