ASPIRATOR/IRRIGATOR OR I/A UNIT
Device Facts
| Record ID | K820889 |
|---|---|
| Device Name | ASPIRATOR/IRRIGATOR OR I/A UNIT |
| Applicant | Mid Laboratories, Inc. |
| Product Code | KYG · Ophthalmic |
| Decision Date | May 5, 1982 |
| 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.
