Normal Saline Flush
FDA 510(k) clearance K150143 · decided 2015-08-31
Clearance details
- K-number
- K150143
- Device name
- Normal Saline Flush
- Applicant
- Nurse Assist, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-01-22
- Decision date
- 2015-08-31
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- NGT
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Haltom City, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 1 recall (Z-0926-2017) | Nurse Assist, Inc | 2017-01-03 |