Clearance Summary
FRAME, SPECTACLE received FDA 510(k) clearance under submission number K873965, sponsored by Swank Plus , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1988-04-01.
- Submission: K873965
- Applicant / Sponsor: Swank Plus , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1988-04-01
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.