The following data is part of a premarket notification filed by Cryomedical Sciences, Inc. with the FDA for Cms Urethral Warmer.
| Device ID | K952895 |
| 510k Number | K952895 |
| Device Name: | CMS URETHRAL WARMER |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYOMEDICAL SCIENCES, INC. 1300 PICCARD DR. Rockville, MD 20850 |
| Contact | Claude C Crawford |
| Correspondent | Claude C Crawford CRYOMEDICAL SCIENCES, INC. 1300 PICCARD DR. Rockville, MD 20850 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-23 |
| Decision Date | 1995-10-24 |