The following data is part of a premarket notification filed by Jiangxi Sanxin (eversincere) Medical Devices Group with the FDA for Yixin Safety Syringe.
| Device ID | K042102 |
| 510k Number | K042102 |
| Device Name: | YIXIN SAFETY SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP SHAN JIANG ZHEN ROAD Nan Chang, Jiangxi, CN 330204 |
| Contact | Liu Kun Sheng |
| Correspondent | Liu Kun Sheng JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP SHAN JIANG ZHEN ROAD Nan Chang, Jiangxi, CN 330204 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-04 |
| Decision Date | 2005-03-08 |