DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE
Device Facts
| Record ID | K945171 |
|---|---|
| Device Name | DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE |
| Applicant | Boston Surgical Products, Inc. |
| Product Code | KYG · Ophthalmic |
| Decision Date | Feb 8, 1995 |
| 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.
