SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
FDA 510(k) clearance K060390 · decided 2006-04-27
Clearance details
- K-number
- K060390
- Device name
- SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
- Applicant
- Galil Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-14
- Decision date
- 2006-04-27
- Days to decision
- 72 days
- Clearance type
- Special
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in recall (Z-1031-2011) | Galil Medical, Inc. | 2011-02-03 |