Clearance Summary
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS received FDA 510(k) clearance under submission number K130117, sponsored by Network Medical Products, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2013-10-29.
- Submission: K130117
- Applicant / Sponsor: Network Medical Products, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4790
- Decision date: 2013-10-29
Classification & Regulation
This clearance is catalogued under FDA product code HOZ and 21 CFR 886.4790, within the Ophthalmic review panel as a Class II device.