The following data is part of a premarket notification filed by Michael Reynard, M.d. with the FDA for Iris Retracting Phacoemulsification Sleeve.
| Device ID | K002812 |
| 510k Number | K002812 |
| Device Name: | IRIS RETRACTING PHACOEMULSIFICATION SLEEVE |
| Classification | Unit, Phacofragmentation |
| Applicant | MICHAEL REYNARD, M.D. 1301-20TH ST., #260 Santa Monica, CA 90404 |
| Contact | Michael Reynard |
| Correspondent | Michael Reynard MICHAEL REYNARD, M.D. 1301-20TH ST., #260 Santa Monica, CA 90404 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-08 |
| Decision Date | 2000-11-08 |