Clearance Summary
ML-DISPOSABLE PAK received FDA 510(k) clearance under submission number K972522, sponsored by Med-Logics, 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 1997-09-30.
- Submission: K972522
- Applicant / Sponsor: Med-Logics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4150
- Decision date: 1997-09-30
Classification & Regulation
This clearance is catalogued under FDA product code MSR and 21 CFR 886.4150, within the Ophthalmic review panel as a Class II device.