Shanghai Bright Kun Industrial Limited · 89-08 · CHINA
For Shanghai Bright Kun Industrial Limited · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is Derma Needle Roller | Derma Needle Roller; product code is 79 G - - ED Brush, Dermabrasion, Manual | 89 K - - NM Device, Pressure Applying; date published is 02/14/2017; address is D218 No.168 Jiugan Road , Shanghai, Shanghai CHINA, verified against its source on 2026-09-16.
- Firm
- Shanghai Bright Kun Industrial Limited verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- D218 No.168 Jiugan Road , Shanghai, Shanghai CHINA verified
- Date published
- 02/14/2017 verified
- Product code
- 79 G - - ED Brush, Dermabrasion, Manual | 89 K - - NM Device, Pressure Applying each item verified
- Product
- Derma Needle Roller | Derma Needle Roller each item verified
- FDA notes
- Class I device without a valid 510k | Class I device without a valid 510k each item verified
What the source says
Shanghai Bright Kun Industrial Limited Date Published : 02/14/2017 D218 No.168 Jiugan Road , Shanghai, Shanghai CHINA 79 G - - ED Brush, Dermabrasion, Manual Date Published: 02/14/2017 Desc: Derma Needle Roller Notes: Class I device without a valid 510k 89 K - - NM Device, Pressure Applying Date Published: 02/14/2017 Desc: Derma Needle Roller Notes: Class I device without a valid 510k
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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