Clearance Summary
PUNCH SURGICAL received FDA 510(k) clearance under submission number K933772, sponsored by Mahe-Medizintechnik. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1994-02-01.
- Submission: K933772
- Applicant / Sponsor: Mahe-Medizintechnik
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1994-02-01
Classification & Regulation
This clearance is catalogued under FDA product code LXH and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.