Excelsior Leather & Plastic Ind. Co., Ltd · 89-08 · CHINA
For Excelsior Leather & Plastic Ind. Co., Ltd · 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 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 2026-09-16.
- 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 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).
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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