Excelsior Leather & Plastic Ind. Co., Ltd · 89-08 · CHINA
For Excelsior Leather & Plastic Ind. Co., Ltd, 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 Smart Swab | Smart Swab; product code is 77 J - - YG Curette, Ear | 77 J - - YT Pick, Microsurgical Ear; date published is 02/10/2017; address is Eastern Industrial , Zone Hung Yip , Zhu Hai City, Guang Dong CHINA, verified against its source on 2026-09-30.
- Firm
- Excelsior Leather & Plastic Ind. Co., Ltd 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
- Eastern Industrial , Zone Hung Yip , Zhu Hai City, Guang Dong CHINA verified
- Date published
- 02/10/2017 verified
- Product code
- 77 J - - YG Curette, Ear | 77 J - - YT Pick, Microsurgical Ear each item verified
- Product
- Smart Swab | Smart Swab each item verified
- FDA notes
- Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k). | Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k). each item verified
What the source says
Excelsior Leather & Plastic Ind. Co., Ltd Date Published : 02/10/2017 Eastern Industrial , Zone Hung Yip , Zhu Hai City, Guang Dong 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
77 J - - YG Curette, Ear Date Published: 02/10/2017 Desc: Smart Swab Notes: Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k). 77 J - - YT Pick, Microsurgical Ear Date Published: 02/10/2017 Desc: Smart Swab Notes: Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k).
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html