Technic Star Universal · 89-08 · HONG KONG SAR
For Technic Star Universal · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is Shaker Teether Toy | Gel Filled Infant Teether; product code is 76 K - - KO Ring, Teething, Fluid-Filled | 76 K - - KO Ring, Teething, Fluid-Filled; date published is 01/23/2019; address is Limited Room 1013 Hung To Road , Road No. 1 Kwun Tong , Kowloon, HONG KONG SAR, verified against its source on 2026-09-16.
- Firm
- Technic Star Universal 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
- HONG KONG SAR verified
- Address
- Limited Room 1013 Hung To Road , Road No. 1 Kwun Tong , Kowloon, HONG KONG SAR verified
- Date published
- 01/23/2019 verified
- Product code
- 76 K - - KO Ring, Teething, Fluid-Filled | 76 K - - KO Ring, Teething, Fluid-Filled each item verified
- Product
- Shaker Teether Toy | Gel Filled Infant Teether each item verified
- FDA notes
- Class II; 10/5/2009 | Class II; 10/5/2009 each item verified
What the source says
Technic Star Universal Date Published : 01/23/2019 Limited Room 1013 Hung To Road , Road No. 1 Kwun Tong , Kowloon, HONG KONG SAR 76 K - - KO Ring, Teething, Fluid-Filled Date Published: 01/23/2019 Desc: Shaker Teether Toy Notes: Class II; 10/5/2009 76 K - - KO Ring, Teething, Fluid-Filled Date Published: 01/23/2019 Desc: Gel Filled Infant Teether Notes: Class II; 10/5/2009
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.