The following data is part of a premarket notification filed by Crymed Technologies, Inc. with the FDA for Spraygenix Cryo Ablation System.
| Device ID | K060555 |
| 510k Number | K060555 |
| Device Name: | SPRAYGENIX CRYO ABLATION SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYMED TECHNOLOGIES, INC. 3225 ELLERSLIE AVE. THIRD FLOOR, STE. B311 Baltimore, MD 21218 |
| Contact | Tim Askew |
| Correspondent | Tim Askew CRYMED TECHNOLOGIES, INC. 3225 ELLERSLIE AVE. THIRD FLOOR, STE. B311 Baltimore, MD 21218 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-02 |
| Decision Date | 2006-04-21 |
| Summary: | summary |