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 |