Reference Source

Lucky Board Manufacturing · 89-08 · CHINA

For Lucky Board Manufacturing · 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 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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 80 F - - XX Mask, Surgical Date Published: 11/08/2018 Desc: Surgical Mask Notes: Class II

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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