HMS · Drum, Eye Knife Test
Ophthalmic · 21 CFR 886.4230 · Class 1
Overview
| Product Code | HMS |
|---|---|
| Device Name | Drum, Eye Knife Test |
| Regulation | 21 CFR 886.4230 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K926412 | MICRON-SCOPE II | Chiron Vision Corp. | Jul 19, 1994 | SESE |
Top Applicants
- Chiron Vision Corp. — 1 clearance
