The following data is part of a premarket notification filed by Zxtgy (beijing) Technology Co., Ltd with the FDA for Diazir.
Device ID | K161652 |
510k Number | K161652 |
Device Name: | DIAZIR |
Classification | Powder, Porcelain |
Applicant | ZXTGY (BEIJING) TECHNOLOGY CO., LTD 132 JINGCHEN RUNYE COURTYARD 7 ZONE 2 WANGSIYING INDUSTRIAL BASE, CHAOYANG DISTRICT Beijing, CN 100023 |
Contact | N/a N/a |
Correspondent | John G. Huang PROMY CHEMICAL, INC. 130 TRAVALINI COURT El Sobrante, CA 94803 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-15 |
Decision Date | 2017-11-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIAZIR 85605305 4345411 Live/Registered |
ARDENT, INC. 2012-04-23 |