Technic Star Universal · 89-08 · HONG KONG SAR
For Technic Star Universal, import alert is 89-08; country is HONG KONG SAR; 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 Gel Filled Infant Teether | Shaker Teether Toy; 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 2026-09-30.
- 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
- Gel Filled Infant Teether | Shaker Teether Toy 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
— accessdata.fda.gov, retrieved 2026-09-22
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
76 K - - KO Ring, Teething, Fluid-Filled Date Published: 01/23/2019 Desc: Gel Filled Infant Teether Notes: Class II; 10/5/2009 76 K - - KO Ring, Teething, Fluid-Filled Date Published: 01/23/2019 Desc: Shaker Teether Toy Notes: Class II; 10/5/2009
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html