The following data is part of a premarket notification filed by Northern Scientific, Inc. with the FDA for Csm Medium.
| Device ID | K854052 |
| 510k Number | K854052 |
| Device Name: | CSM MEDIUM |
| Classification | Media, Corneal Storage |
| Applicant | NORTHERN SCIENTIFIC, INC. 688 MAIN ST. Buffalo, NY 14202 |
| Contact | Robert W Case |
| Correspondent | Robert W Case 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 | 1985-10-03 |
| Decision Date | 1985-12-31 |