Clearance Summary
WEE-PEEPERS (CUSHIONED CHILDREN'S SUNSHADES) received FDA 510(k) clearance under submission number K897089, sponsored by Inno-Lite Co., 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 1990-04-23.
- Submission: K897089
- Applicant / Sponsor: Inno-Lite Co., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1990-04-23
Classification & Regulation
This clearance is catalogued under FDA product code HQZ and 21 CFR 886.5842, within the Ophthalmic review panel as a Class I device.