Clearance Summary
RELIANCE OPHTHALMIC INSTRUMENT CONTROL received FDA 510(k) clearance under submission number K812544, sponsored by F. & F. Koenigkramer. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1981-09-21.
- Submission: K812544
- Applicant / Sponsor: F. & F. Koenigkramer
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1860
- Decision date: 1981-09-21
Classification & Regulation
This clearance is catalogued under FDA product code HMF and 21 CFR 886.1860, within the Ophthalmic review panel as a Class I device.