Clearance Summary
HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 received FDA 510(k) clearance under submission number K003337, sponsored by Weck Closure Systems. 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 2000-12-21.
- Submission: K003337
- Applicant / Sponsor: Weck Closure Systems
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2000-12-21
Classification & Regulation
This clearance is catalogued under FDA product code FZP and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.