The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Ltd. with the FDA for Sterile Hypodermic Safety Syringes For Single Use.
Device ID | K163162 |
510k Number | K163162 |
Device Name: | Sterile Hypodermic Safety Syringes For Single Use |
Classification | Syringe, Antistick |
Applicant | JiangXi HongDa Medical Equipment Group Ltd. No. 39 South Shengli Road, Jinxian County Nanchang, CN 331700 |
Contact | Yang Xiaohua |
Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-10 |
Decision Date | 2017-03-20 |
Summary: | summary |