Clearance Summary
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY received FDA 510(k) clearance under submission number K051103, sponsored by Haag-Streit USA, 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 2005-06-07.
- Submission: K051103
- Applicant / Sponsor: Haag-Streit USA, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1385
- Decision date: 2005-06-07
Classification & Regulation
This clearance is catalogued under FDA product code HJK and 21 CFR 886.1385, within the Ophthalmic review panel as a Class II device.