SEEDNET, MODELS FP6T5, FP5T5, FP5T3
FDA 510(k) clearance K010991 · decided 2001-05-03
Clearance details
- K-number
- K010991
- Device name
- SEEDNET, MODELS FP6T5, FP5T5, FP5T3
- Applicant
- Galil Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-03
- Decision date
- 2001-05-03
- Days to decision
- 30 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 |
|---|---|---|
| Urethral Warmer System Model number FPRCH3001 The Urethral Warming System is designed to c recall (Z-0832-2011) | Galil Medical | 2010-12-29 |