C-MATE #CMU 1001
Device Facts
| Record ID | K880062 |
|---|---|
| Device Name | C-MATE #CMU 1001 |
| Applicant | O.R. Specialties, Inc. |
| Product Code | HQC · Ophthalmic |
| Decision Date | Mar 7, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4670 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
