Clearance Summary
SIGMA-BRILLEN (OR) MULTIPLE received FDA 510(k) clearance under submission number K930956, sponsored by Sigma-Brillen. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1993-10-20.
- Submission: K930956
- Applicant / Sponsor: Sigma-Brillen
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1993-10-20
Classification & Regulation
This clearance is catalogued under FDA product code HQZ and 21 CFR 886.5842, within the Ophthalmic review panel as a Class I device.