The following data is part of a premarket notification filed by Dutch Ophthalmic Usa, Inc. with the FDA for Fiber Optic Endoillumination Probe.
| Device ID | K980636 |
| 510k Number | K980636 |
| Device Name: | FIBER OPTIC ENDOILLUMINATION PROBE |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| 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 | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-19 |
| Decision Date | 1998-05-20 |
| Summary: | summary |