FDA Product Code
FDA Product Code HRG — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4070
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K013151 | ASMOTOM AUTOMATED TREPHINE SYSTEM | Bkg Opthalmics USA, Inc. | 2001-12-14 | Traditional | PDF ↗ |
| K981063 | AUTOMATED CORNEAL TREPHINE | Laser Center Dev. Corp. | 1998-06-23 | Traditional | PDF ↗ |
| K843957 | ULTRATHIN/SP LENS | Optical Systems Intl., Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K841515 | SCANLAN VASCU-STATT II | Scanlan Intl., Inc. | 1984-06-05 | Traditional | PDF ↗ |
| K823901 | TREPHINE BLADES-VARIOUS MODELS | Edward Weck, Inc. | 1983-01-17 | Traditional | PDF ↗ |
| K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) | Intl. Ophthalmic Industries Corp. | 1979-11-05 | Traditional | PDF ↗ |
Product code HRG · Class I · Ophthalmic. Data: openFDA.