FEEL-JECT INSULIN SYRINGE
FDA 510(k) clearance K070917 · decided 2007-06-20
Clearance details
- K-number
- K070917
- Device name
- FEEL-JECT INSULIN SYRINGE
- Applicant
- Feel Tech
- Decision
- Substantially Equivalent
- Date received
- 2007-04-02
- Decision date
- 2007-06-20
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged recall (Z-1504-2009) | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals | 2009-06-24 |