Clearance Summary
NIL received FDA 510(k) clearance under submission number K943613, sponsored by Sing Wah International Enterprises , 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 1994-09-21.
- Submission: K943613
- Applicant / Sponsor: Sing Wah International Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5840
- Decision date: 1994-09-21
Classification & Regulation
This clearance is catalogued under FDA product code HOI and 21 CFR 886.5840, within the Ophthalmic review panel as a Class I device.