INJEKT SYRINGE
FDA 510(k) clearance K063280 · decided 2006-11-17
Clearance details
- K-number
- K063280
- Device name
- INJEKT SYRINGE
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-31
- Decision date
- 2006-11-17
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Allentown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or wi recall (Z-2643-2023) | B. Braun Medical, Inc. | 2023-09-27 |
| B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) o recall (Z-2644-2023) | B. Braun Medical, Inc. | 2023-09-27 |