Clearance Summary
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS received FDA 510(k) clearance under submission number K861057, sponsored by Precision-Cosmet Co., 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 1986-04-24.
- Submission: K861057
- Applicant / Sponsor: Precision-Cosmet Co., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1986-04-24
Classification & Regulation
This clearance is catalogued under FDA product code HNR and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.