The following data is part of a premarket notification filed by Jiangsu Suyun Medical Material Co., Ltd. with the FDA for Sterile Syringe For Single Use.
Device ID | K210914 |
510k Number | K210914 |
Device Name: | Sterile Syringe For Single Use |
Classification | Syringe, Piston |
Applicant | Jiangsu Suyun Medical Material Co., Ltd. No.18 Jinqiao Road, Dapu Industrial Park Lianyungang, CN 222000 |
Contact | Guangning Xu |
Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-03-29 |
Decision Date | 2021-12-17 |