Clearance Summary
CUSTOM OCULAR PROSTHESIS received FDA 510(k) clearance under submission number K946226, sponsored by Frank Tanaka, Ocularist, 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 1995-03-22.
- Submission: K946226
- Applicant / Sponsor: Frank Tanaka, Ocularist, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.3200
- Decision date: 1995-03-22
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.