Clearance Summary
OXBORO-MEDICAL CAUTERY TIP CLEANER received FDA 510(k) clearance under submission number K952784, sponsored by Oxboro Medical Intl., 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 1995-07-13.
- Submission: K952784
- Applicant / Sponsor: Oxboro Medical Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4115
- Decision date: 1995-07-13
Classification & Regulation
This clearance is catalogued under FDA product code HQP and 21 CFR 886.4115, within the Ophthalmic review panel as a Class II device.