Clearance Summary
HEDGES CORNEAL WETTING PAK received FDA 510(k) clearance under submission number K970161, sponsored by Hedges Cwp, 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 1997-03-25.
- Submission: K970161
- Applicant / Sponsor: Hedges Cwp, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4360
- Decision date: 1997-03-25
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.