Clearance Summary
MADDOX LENS SPATULA CAT. #7245 received FDA 510(k) clearance under submission number K801609, sponsored by Edward Weck, 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 1980-08-13.
- Submission: K801609
- Applicant / Sponsor: Edward Weck, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1980-08-13
Classification & Regulation
This clearance is catalogued under FDA product code HND and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.