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 |