The following data is part of a premarket notification filed by Yonghe Plastic Products Co., Ltd. with the FDA for Yonghe.
Device ID | K140244 |
510k Number | K140244 |
Device Name: | YONGHE |
Classification | Vinyl Patient Examination Glove |
Applicant | YONGHE PLASTIC PRODUCTS CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD Haidan Dis, Beijing, CN 100083 |
Contact | Chu Xiaoan |
Correspondent | Chu Xiaoan YONGHE PLASTIC PRODUCTS CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD Haidan Dis, Beijing, CN 100083 |
Product Code | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-30 |
Decision Date | 2014-11-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
YONGHE 90485972 not registered Live/Pending |
Youjian Lin 2021-01-25 |