Clearance Summary
BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON received FDA 510(k) clearance under submission number K864520, sponsored by Precision Instruments, 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 1987-01-20.
- Submission: K864520
- Applicant / Sponsor: Precision Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1987-01-20
Classification & Regulation
This clearance is catalogued under FDA product code HRH and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.