The following data is part of a premarket notification filed by Dutch Ophthalmic Usa, Inc. with the FDA for D.o.r.c. Harmony Total Vitrectomy System.
| Device ID | K983797 |
| 510k Number | K983797 |
| Device Name: | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. Kingston, NH 03848 |
| Contact | Mark W Furlong |
| Correspondent | Mark W Furlong DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. Kingston, NH 03848 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-28 |
| Decision Date | 1999-03-03 |
| Summary: | summary |