Surgin, Inc. · Class I · Cleared Dec 13, 2001
| K-number | K013337 |
| Device name | PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI |
| Applicant | Surgin, Inc. |
| Product code | HNO |
| Device class | Class I |
| Decision date | Dec 13, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 886.4370 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov