FDA Product Code
FDA Product Code HLR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1350
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K901553 | SURG-K SURGICAL KERATOMETER | The Sanborn Co. | 1990-07-20 | Traditional | PDF ↗ |
| K882902 | QRK 100, QUALITATIVE RING KERATOSCOPE | Technitex, Inc. | 1988-08-04 | Traditional | PDF ↗ |
| K882618 | JEDMED/POLACK KERATOSCOPE HS/SL | Gamut Ent. | 1988-07-13 | Traditional | PDF ↗ |
| K864639 | REUSABLE SURGICAL KERATOSCOPE | Jedmed Instrument Co. | 1986-12-29 | Traditional | PDF ↗ |
| K854054 | PLACIDO DISC | Cutler Medical Instruments | 1985-12-27 | Traditional | PDF ↗ |
| K830008 | KARICKHOFF KERATOSCOPE | Surgidev Corp. | 1983-01-26 | Traditional | PDF ↗ |
| K821080 | HAND KERATOSCOPE | Medical Equipment Designs, Inc. | 1982-05-24 | Traditional | PDF ↗ |
Product code HLR · Class I · Ophthalmic. Data: openFDA.