The following data is part of a premarket notification filed by Cryomedical Sciences, Inc. with the FDA for Cms Oncoprobe (tm).
| Device ID | K904421 |
| 510k Number | K904421 |
| Device Name: | CMS ONCOPROBE (TM) |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYOMEDICAL SCIENCES, INC. THREE BETHESDA METRO CDENTER SUITE 700 Bethesda, MD 20814 |
| Contact | Finkelstien |
| Correspondent | Finkelstien CRYOMEDICAL SCIENCES, INC. THREE BETHESDA METRO CDENTER SUITE 700 Bethesda, MD 20814 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-27 |
| Decision Date | 1991-04-08 |