Clearance Summary
MED-LOGICS DISPOSABLE ALK TUBING received FDA 510(k) clearance under submission number K010353, 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 2001-04-27.
- Submission: K010353
- Applicant / Sponsor: Med-Logics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4360
- Decision date: 2001-04-27
Classification & Regulation
This clearance is catalogued under FDA product code KYG and 21 CFR 886.4360, within the Ophthalmic review panel as a Class I device.