NCI SPATULA
Device Facts
| Record ID | K110734 |
|---|---|
| Device Name | NCI SPATULA |
| Applicant | Fischer Surgical, Inc. |
| Product Code | OTZ · Ophthalmic |
| Decision Date | May 31, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4300 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
