Clearance Summary
REMOVER, SOFT-SERT CONTACT LENS received FDA 510(k) clearance under submission number K782140, sponsored by Mcmurray and Pendergost. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1979-02-12.
- Submission: K782140
- Applicant / Sponsor: Mcmurray and Pendergost
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5420
- Decision date: 1979-02-12
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.