The following data is part of a premarket notification filed by Jiangxi Sanxin (eversincere) Medical Devices Group with the FDA for Yi Xin Sterile Syringe For Single Use.
| Device ID | K050999 |
| 510k Number | K050999 |
| Device Name: | YI XIN STERILE SYRINGE FOR SINGLE USE |
| Classification | Syringe, Piston |
| Applicant | JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP SHANJIANG ROAD Nanchang, Jiangxi, CN 330204 |
| Contact | Yun Yuan Gao |
| Correspondent | Yun Yuan Gao JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP SHANJIANG ROAD Nanchang, Jiangxi, CN 330204 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-20 |
| Decision Date | 2005-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20858835007008 | K050999 | 000 |
| 16945060501078 | K050999 | 000 |
| 16945060501085 | K050999 | 000 |
| 16945060501092 | K050999 | 000 |
| 16945060501108 | K050999 | 000 |
| 16945060501115 | K050999 | 000 |
| 16945060501122 | K050999 | 000 |
| 16945060501139 | K050999 | 000 |
| 16945060501146 | K050999 | 000 |
| 16945060501153 | K050999 | 000 |
| 16945060501160 | K050999 | 000 |
| 16945060500019 | K050999 | 000 |
| 16945060501061 | K050999 | 000 |
| 16945060501054 | K050999 | 000 |
| 16945060501047 | K050999 | 000 |
| 20858835007015 | K050999 | 000 |
| 20858835007022 | K050999 | 000 |
| 20858835007039 | K050999 | 000 |
| 20858835007046 | K050999 | 000 |
| 20858835007053 | K050999 | 000 |
| 20858835007954 | K050999 | 000 |
| 20858835007961 | K050999 | 000 |
| 20858835007978 | K050999 | 000 |
| 16945060501016 | K050999 | 000 |
| 16945060501023 | K050999 | 000 |
| 16945060501030 | K050999 | 000 |
| 16945060500026 | K050999 | 000 |
| 16945060500033 | K050999 | 000 |
| 16945060500040 | K050999 | 000 |
| B031AH03S2 | K050999 | 000 |
| B031AH05L2 | K050999 | 000 |
| B031AH05S2 | K050999 | 000 |
| B031AH10L2 | K050999 | 000 |
| B031AH10S2 | K050999 | 000 |
| B031AH20L2 | K050999 | 000 |
| B031AH20S2 | K050999 | 000 |
| B031AH30L2 | K050999 | 000 |
| B031AH30S2 | K050999 | 000 |
| B031AH60C2 | K050999 | 000 |
| B031AH60L2 | K050999 | 000 |
| B031AH03L2 | K050999 | 000 |
| B031AH01T0 | K050999 | 000 |
| 16945060500163 | K050999 | 000 |
| 16945060500057 | K050999 | 000 |
| 16945060500064 | K050999 | 000 |
| 16945060500071 | K050999 | 000 |
| 16945060500088 | K050999 | 000 |
| 16945060500095 | K050999 | 000 |
| 16945060500101 | K050999 | 000 |
| 16945060500118 | K050999 | 000 |
| 16945060500125 | K050999 | 000 |
| 16945060500132 | K050999 | 000 |
| 16945060500149 | K050999 | 000 |
| 16945060500156 | K050999 | 000 |
| B031AH60S2 | K050999 | 000 |