The following data is part of a premarket notification filed by Jiangxi Kelun Medical Devices Manufacturing Co.,lt with the FDA for Single Use Sterile Syringe With Needle.
| Device ID | K133493 |
| 510k Number | K133493 |
| Device Name: | SINGLE USE STERILE SYRINGE WITH NEEDLE |
| Classification | Syringe, Piston |
| Applicant | JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO.,LT ROOM 302, NO.21 BUILDING KAIYU GARDEN, XISHAN SOUTH ROAD Wenzhou, CN 325000 |
| Contact | Helen Nan |
| Correspondent | Helen Nan JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO.,LT ROOM 302, NO.21 BUILDING KAIYU GARDEN, XISHAN SOUTH ROAD Wenzhou, CN 325000 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-14 |
| Decision Date | 2014-03-27 |
| Summary: | summary |