The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Model C2100-series Ophthalmic Cryoprobe.
| Device ID | K810409 |
| 510k Number | K810409 |
| Device Name: | MODEL C2100-SERIES OPHTHALMIC CRYOPROBE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | VALLEYLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-18 |
| Decision Date | 1981-03-20 |