The following data is part of a premarket notification filed by Eye-deal Ocular Safety Products, Inc. with the FDA for Eye Irrigator Model #2020.
| Device ID | K980647 |
| 510k Number | K980647 |
| Device Name: | EYE IRRIGATOR MODEL #2020 |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | EYE-DEAL OCULAR SAFETY PRODUCTS, INC. P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan EYE-DEAL OCULAR SAFETY PRODUCTS, INC. P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-05-15 |
| Summary: | summary |