The following data is part of a premarket notification filed by Dutch Ophthalmic Research Center (d.o.r.c.) with the FDA for Dorc Vitrectomy Lenses, Model 1284 Series.
| Device ID | K033950 |
| 510k Number | K033950 |
| Device Name: | DORC VITRECTOMY LENSES, MODEL 1284 SERIES |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.) ONE LITTLE RIVER ROAD Kingston, NH 03848 |
| Contact | Fran Carleton |
| Correspondent | Fran Carleton DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.) ONE LITTLE RIVER ROAD Kingston, NH 03848 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-02-20 |
| Summary: | summary |