AUTOPOLE REGULATOR SYSTEM
Device Facts
| Record ID | K924999 |
|---|---|
| Device Name | AUTOPOLE REGULATOR SYSTEM |
| Applicant | Escalon Trek Medical |
| Product Code | KYG · Ophthalmic |
| Decision Date | Dec 24, 1992 |
| 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.
