The following data is part of a premarket notification filed by Dutch Ophthalmic Usa, Inc. with the FDA for D.o.r.c. Vfi/vfe System.
| Device ID | K954842 |
| 510k Number | K954842 |
| Device Name: | D.O.R.C. VFI/VFE SYSTEM |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | DUTCH OPHTHALMIC USA, INC. TWO MARSHALL RD. Kingston, NH 03848 |
| Contact | Mark W Furlong |
| Correspondent | Mark W Furlong DUTCH OPHTHALMIC USA, INC. TWO MARSHALL RD. Kingston, NH 03848 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-23 |
| Decision Date | 1996-04-15 |