Clearance Summary
3 IN 1 AUTOMATIC TOURNIQUET received FDA 510(k) clearance under submission number K880020, sponsored by Systematics Mfg. & Tool Co., Inc.. 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 1988-03-17.
- Submission: K880020
- Applicant / Sponsor: Systematics Mfg. & Tool Co., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5910
- Decision date: 1988-03-17
Classification & Regulation
This clearance is catalogued under FDA product code KCY and 21 CFR 878.5910, within the General, Plastic Surgery review panel as a Class I device.