MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
FDA 510(k) clearance K091583 · decided 2010-01-28
Clearance details
- K-number
- K091583
- Device name
- MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
- Applicant
- Medefil, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-02
- Decision date
- 2010-01-28
- Days to decision
- 240 days
- Clearance type
- Special
- Product code
- NGT
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Glendale Heights, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/C recall (Z-1619-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |