JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)
FDA 510(k) clearance K103830 · decided 2011-07-29
Clearance details
- K-number
- K103830
- Device name
- JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)
- Applicant
- Jiangsu Shenli Medical Production Factory
- Decision
- Substantially Equivalent
- Date received
- 2010-12-30
- Decision date
- 2011-07-29
- Days to decision
- 211 days
- Clearance type
- Abbreviated
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mosely, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSY recall (Z-3033-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-09-06 |
| McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRI recall (Z-2940-2024) | Cypress Medical Products LLC | 2024-08-29 |