Clearance Summary
ROBERT B. SCOTT PLASTIC ARTIFICAL received FDA 510(k) clearance under submission number K952538, sponsored by Robert B. Scott Ocularists of Florida, 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 1995-06-26.
- Submission: K952538
- Applicant / Sponsor: Robert B. Scott Ocularists of Florida, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.3200
- Decision date: 1995-06-26
Classification & Regulation
This clearance is catalogued under FDA product code HQH and 21 CFR 886.3200, within the Ophthalmic review panel as a Class I device.