The following data is part of a premarket notification filed by Advanced Medical Optics, Inc. with the FDA for Vitrectomy Cutter And Accessories.
| Device ID | K081681 |
| 510k Number | K081681 |
| Device Name: | VITRECTOMY CUTTER AND ACCESSORIES |
| Classification | Vitrectomy, Instrument Cutter |
| Applicant | ADVANCED MEDICAL OPTICS, INC. 1700 E. ST. ANDREW PLACE P.O. BOX 25162 Santa Ana, CA 92705 -4933 |
| Contact | Evelyn De La Vega |
| Correspondent | Evelyn De La Vega ADVANCED MEDICAL OPTICS, INC. 1700 E. ST. ANDREW PLACE P.O. BOX 25162 Santa Ana, CA 92705 -4933 |
| Product Code | MLZ |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-10-08 |
| Summary: | summary |