FDA Product Code
FDA Product Code HKP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4150
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K952558 | AARON VAC 2 | Aaron Medical Industries | 1997-03-19 | Traditional | PDF ↗ |
| K950056 | THE GRIESHABER AXIAL CUTTER | Grieshaber & Co. | 1995-05-05 | Traditional | PDF ↗ |
| K950287 | UNIVIT PROBE | Medical Instrument Development Laboratories, Inc. | 1995-04-10 | Traditional | PDF ↗ |
| K896622 | VISITEC VITRECTOMY UNIT | Visitec Co. | 1990-04-04 | Traditional | PDF ↗ |
| K890595 | MENTOR ANTERIOR SEGMENT VITRECTOR | Mentor O & O, Inc. | 1989-04-17 | Traditional | PDF ↗ |
| K832074 | CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA | CooperVision, Inc. | 1983-08-01 | Traditional | PDF ↗ |
| K822599 | KEATES I/A SYSTEM FRIGITRONICS 4000 | Frigitronics of Connecticut, Inc. | 1982-10-06 | Traditional | PDF ↗ |
| K813273 | EMERGENCY POWER PAC (EMPAC) | Optical Micro Systems, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K810152 | X-VEE | Temporaty Surgical Systems | 1981-03-17 | Traditional | PDF ↗ |
| K801231 | EYE-VAC | Coburn Optical Ind., Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K791898 | OCUTOME MODEL 8000 | Cooper Medical Devices Corp. | 1979-10-30 | Traditional | PDF ↗ |
| K791000 | VITREOUS SUCTION/CUTTER | Concept, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K790893 | STAT | Varian Assoc., Inc. | 1979-08-28 | Traditional | PDF ↗ |
| K780852 | CLINITEX VIS-X ASPIRATING ACCESSORY | Varian Assoc., Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K761353 | VITEROUS SUCTION CUTTER | Concept, Inc. | 1977-01-05 | Traditional | PDF ↗ |
| K760684 | VISC X-VITREOUS ASPIRATING & CUT. INSTR | Varian Assoc., Inc. | 1976-10-05 | Traditional | PDF ↗ |
Product code HKP · Class II · Ophthalmic. Data: openFDA.