Clearance Summary
CONTACT LENS TWEEZERS received FDA 510(k) clearance under submission number K871130, sponsored by S. M. C. Medi-Tech Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-05-12.
- Submission: K871130
- Applicant / Sponsor: S. M. C. Medi-Tech Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5420
- Decision date: 1987-05-12
Classification & Regulation
This clearance is catalogued under FDA product code KYE and 21 CFR 886.5420, within the Ophthalmic review panel as a Class I device.