The following data is part of a premarket notification filed by Dutch Ophthalmic Research Center International Bv with the FDA for Eva,anterior Machine, Eva, Combined Machine, Eva Combined Machine With Laser(dorc Connector), Eva Combined Machine With Laser Sma Connector).
| Device ID | K142877 |
| 510k Number | K142877 |
| Device Name: | EVA,anterior Machine, EVA, Combined Machine, EVA Combined Machine With Laser(DORC Connector), EVA Combined Machine With Laser SMA Connector) |
| Classification | Unit, Phacofragmentation |
| Applicant | DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEWEG 2 Zuidland, NL 3214 Vn |
| Contact | Danielle Sleegers |
| Correspondent | Danielle Sleegers DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEWEG 2 Zuidland, NL 3214 Vn |
| Product Code | HQC |
| Subsequent Product Code | HQE |
| Subsequent Product Code | HQF |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-01 |
| Decision Date | 2015-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717872025988 | K142877 | 000 |
| 08717872019697 | K142877 | 000 |
| 08717872019703 | K142877 | 000 |
| 08717872019710 | K142877 | 000 |
| 18717872031481 | K142877 | 000 |
| 08717872021041 | K142877 | 000 |
| 08717872021508 | K142877 | 000 |
| 08717872008837 | K142877 | 000 |
| 08717872018645 | K142877 | 000 |
| 08717872018706 | K142877 | 000 |
| 08717872030579 | K142877 | 000 |
| 08717872002972 | K142877 | 000 |
| 08717872007199 | K142877 | 000 |
| 08717872019680 | K142877 | 000 |