Clearance Summary
LOW-POWER BINOCULAR LOUPE received FDA 510(k) clearance under submission number K875124, sponsored by Seiler Instrument & Mfg. Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1988-02-19.
- Submission: K875124
- Applicant / Sponsor: Seiler Instrument & Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4770
- Decision date: 1988-02-19
Classification & Regulation
This clearance is catalogued under FDA product code HOH and 21 CFR 886.4770, within the Ophthalmic review panel as a Class I device.