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 |