TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
Device Facts
| Record ID | K003036 |
|---|---|
| Device Name | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 |
| Applicant | Retinalabs.Com |
| Product Code | KYG · Ophthalmic |
| Decision Date | Dec 22, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4360 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.