Clearance Summary
GOUVERNEUR AUDIGIER received FDA 510(k) clearance under submission number K952758, sponsored by Ets Gouverneur-Audigier. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-08-07.
- Submission: K952758
- Applicant / Sponsor: Ets Gouverneur-Audigier
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1995-08-07
Classification & Regulation
This clearance is catalogued under FDA product code HQY and 21 CFR 886.5850, within the Ophthalmic review panel as a Class I device.