Lucky Board Manufacturing · 89-08 · CHINA
For Lucky Board Manufacturing, import alert is 89-08; country is CHINA; 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)"; product is Surgical Mask; product code is 80 F - - XX Mask, Surgical; date published is 08/30/2013; address is No 34 Pingdi Section, Shen Huei Road , Pingdi Town, Longgong District , Shenzhen, Yandongsheng CHINA, verified against its source on 2026-09-30.
- Firm
- Lucky Board Manufacturing 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
- No 34 Pingdi Section, Shen Huei Road , Pingdi Town, Longgong District , Shenzhen, Yandongsheng CHINA verified
- Date published
- 08/30/2013 verified
- Product code
- 80 F - - XX Mask, Surgical verified
- Product
- Surgical Mask verified
- FDA notes
- Class II verified
What the source says
Lucky Board Manufacturing Date Published : 08/30/2013 No 34 Pingdi Section, Shen Huei Road , Pingdi Town, Longgong District , Shenzhen, Yandongsheng CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
80 F - - XX Mask, Surgical Date Published: 11/08/2018 Desc: Surgical Mask Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html