The following data is part of a premarket notification filed by Jiangsu Shenli Medical Production Factory with the FDA for Jiangsu Shenli Medical Production Co. Ltd. Piston Syringe (5cc Luer Lock).
| Device ID | K103830 |
| 510k Number | K103830 |
| Device Name: | JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) |
| Classification | Syringe, Piston |
| Applicant | JIANGSU SHENLI MEDICAL PRODUCTION FACTORY 15637 FOX COVE CIRCLE Mosely, VA 23120 |
| Contact | Darren Reeves |
| Correspondent | Darren Reeves JIANGSU SHENLI MEDICAL PRODUCTION FACTORY 15637 FOX COVE CIRCLE Mosely, VA 23120 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-30 |
| Decision Date | 2011-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816336022104 | K103830 | 000 |
| 10195327616809 | K103830 | 000 |
| 10195327616427 | K103830 | 000 |
| 10195327616410 | K103830 | 000 |
| 10195327616304 | K103830 | 000 |
| 40193489896788 | K103830 | 000 |
| 40193489896771 | K103830 | 000 |
| 16935550813019 | K103830 | 000 |
| 16935550810117 | K103830 | 000 |
| 16935550810100 | K103830 | 000 |
| 06935550810059 | K103830 | 000 |
| 16935550810032 | K103830 | 000 |
| 06935550810028 | K103830 | 000 |
| 06935550810011 | K103830 | 000 |
| 20853620005382 | K103830 | 000 |
| 20853620005245 | K103830 | 000 |
| 40195327616893 | K103830 | 000 |
| 10195327616946 | K103830 | 000 |
| 16935550810094 | K103830 | 000 |
| 20816336022098 | K103830 | 000 |
| 20816336022081 | K103830 | 000 |
| 20816336022067 | K103830 | 000 |
| 20816336022050 | K103830 | 000 |
| 20816336022234 | K103830 | 000 |
| 20816336022227 | K103830 | 000 |
| 20816336022210 | K103830 | 000 |
| 10842209107343 | K103830 | 000 |
| B2086766600 | K103830 | 000 |
| B2086760603 | K103830 | 000 |
| B2086733303 | K103830 | 000 |
| B2086730303 | K103830 | 000 |
| B2086720203 | K103830 | 000 |
| B2086713503 | K103830 | 000 |
| B2086710203 | K103830 | 000 |
| 10853620005170 | K103830 | 000 |