Clearance Summary
DORC VITRECTOMY LENSES, MODEL 1284 SERIES received FDA 510(k) clearance under submission number K033950, sponsored by Dutch Ophthalmic Research Center (D.O.R.C.). The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2004-02-20.
- Submission: K033950
- Applicant / Sponsor: Dutch Ophthalmic Research Center (D.O.R.C.)
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1385
- Decision date: 2004-02-20
Classification & Regulation
This clearance is catalogued under FDA product code HJK and 21 CFR 886.1385, within the Ophthalmic review panel as a Class II device.