The following data is part of a premarket notification filed by Northern Scientific, Inc. with the FDA for Dexsol.
| Device ID | K883854 |
| 510k Number | K883854 |
| Device Name: | DEXSOL |
| Classification | Media, Corneal Storage |
| Applicant | NORTHERN SCIENTIFIC, INC. 688 MAIN ST. Buffalo, NY 14202 |
| Contact | Carol Houenstein |
| Correspondent | Carol Houenstein NORTHERN SCIENTIFIC, INC. 688 MAIN ST. Buffalo, NY 14202 |
| Product Code | LYX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1988-11-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DEXSOL 74376597 1818714 Dead/Cancelled |
Chiron Corporation 1993-04-07 |