Clearance Summary
SURGICAL INSTRUMENTS REPRESENT. 4 CLASS received FDA 510(k) clearance under submission number K822151, sponsored by Robert I. Chien & Assoc., 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 1982-08-19.
- Submission: K822151
- Applicant / Sponsor: Robert I. Chien & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1982-08-19
Classification & Regulation
This clearance is catalogued under FDA product code HNF and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.