The following data is part of a premarket notification filed by Crymed Technologies, Inc. with the FDA for Crymed Cryo-ablator.
| Device ID | K040809 |
| 510k Number | K040809 |
| Device Name: | CRYMED CRYO-ABLATOR |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYMED TECHNOLOGIES, INC. 319 W. TIMONIUM RD. Lutherville, MD 21093 |
| Contact | Frank Majerowicz |
| Correspondent | Frank Majerowicz CRYMED TECHNOLOGIES, INC. 319 W. TIMONIUM RD. Lutherville, MD 21093 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-05-21 |
| Summary: | summary |