The following data is part of a premarket notification filed by Guangdong Antmed Co., Ltd. with the FDA for Disposable Sterile Syringe, Disposable Sterile Syringe With Needle.
Device ID | K210991 |
510k Number | K210991 |
Device Name: | Disposable Sterile Syringe, Disposable Sterile Syringe With Needle |
Classification | Syringe, Piston |
Applicant | Guangdong Antmed Co., Ltd. Rm 201, Bld 3, Hualian Ave, Songshanhu District Dongguan, CN 523800 |
Contact | Zhiying Zhong |
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 | 2021-04-02 |
Decision Date | 2021-08-26 |