Clearance Summary
D-C-S SYSTEM received FDA 510(k) clearance under submission number K930657, sponsored by Pina-Vertriebs. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1994-06-29.
- Submission: K930657
- Applicant / Sponsor: Pina-Vertriebs
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 1994-06-29
Classification & Regulation
This clearance is catalogued under FDA product code KWP and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.