The following data is part of a premarket notification filed by Dutch Ophthalmic Research Center International Bv with the FDA for Associate 2500 Dual And Compact Systems.
| Device ID | K081877 |
| 510k Number | K081877 |
| Device Name: | ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS |
| Classification | Unit, Phacofragmentation |
| Applicant | DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEG 2 Zuidland, NL 3214 Vn |
| Contact | Ger Vijfvinkel |
| Correspondent | Ger Vijfvinkel DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEG 2 Zuidland, NL 3214 Vn |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-02 |
| Decision Date | 2009-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717872016818 | K081877 | 000 |
| 08717872009896 | K081877 | 000 |
| 08717872009735 | K081877 | 000 |
| 08717872009728 | K081877 | 000 |
| 08717872009711 | K081877 | 000 |
| 08717872009032 | K081877 | 000 |
| 08717872008943 | K081877 | 000 |
| 08717872008929 | K081877 | 000 |
| 08717872002415 | K081877 | 000 |
| 08717872017594 | K081877 | 000 |
| 08717872016627 | K081877 | 000 |
| 08717872013428 | K081877 | 000 |
| 08717872001418 | K081877 | 000 |
| 08717872013404 | K081877 | 000 |
| 08717872013411 | K081877 | 000 |
| 08717872009155 | K081877 | 000 |
| 08717872009124 | K081877 | 000 |
| 08717872009087 | K081877 | 000 |
| 08717872008974 | K081877 | 000 |
| 08717872008967 | K081877 | 000 |
| 08717872008950 | K081877 | 000 |
| 08717872017686 | K081877 | 000 |
| 08717872017679 | K081877 | 000 |
| 08717872017174 | K081877 | 000 |
| 08717872015026 | K081877 | 000 |
| 08717872013503 | K081877 | 000 |
| 08717872013442 | K081877 | 000 |
| 08717872001395 | K081877 | 000 |