The following data is part of a premarket notification filed by Ophthalmic Solutions, Llc. with the FDA for The Fremstad Ring.
| Device ID | K982599 |
| 510k Number | K982599 |
| Device Name: | THE FREMSTAD RING |
| Classification | Sponge, Ophthalmic |
| Applicant | OPHTHALMIC SOLUTIONS, LLC. 2179 NORTHLAKE PKWY., BLDG. 5 SUITE 115 Tucker, GA 30084 |
| Contact | Daria A Fremstad |
| Correspondent | Daria A Fremstad OPHTHALMIC SOLUTIONS, LLC. 2179 NORTHLAKE PKWY., BLDG. 5 SUITE 115 Tucker, GA 30084 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-27 |
| Decision Date | 1999-02-16 |
| Summary: | summary |