Clearance Summary
PRO-TEC-CASE received FDA 510(k) clearance under submission number K950530, sponsored by Hyman, Phelps & McNamara, P.C.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-04-07.
- Submission: K950530
- Applicant / Sponsor: Hyman, Phelps & McNamara, P.C.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 1995-04-07
Classification & Regulation
This clearance is catalogued under FDA product code LRX and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.