Clearance Summary
RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 received FDA 510(k) clearance under submission number K853149, 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 1985-09-05.
- Submission: K853149
- Applicant / Sponsor: F. & F. Koenigkramer
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1140
- Decision date: 1985-09-05
Classification & Regulation
This clearance is catalogued under FDA product code HME and 21 CFR 886.1140, within the Ophthalmic review panel as a Class I device.