Kenmajor Ent. Co., · 89-08 · TAIWAN
For Kenmajor Ent. Co.,, import alert is 89-08; country is TAIWAN; 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 Glass Eye Wash Cup | Glass Eye Wash Cup; product code is 52 A - - 36 Tumbler, drinking (container w/o handle, w/o stem & w/o foot)(Foodware/Cookware/Table | 86 L - - XQ Cup, Eye; date published is 06/13/2012; address is Sec.5 Sinty , Taipei City, TAIWAN, verified against its source on 2026-09-30.
- Firm
- Kenmajor Ent. Co., 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
- TAIWAN verified
- Address
- Sec.5 Sinty , Taipei City, TAIWAN verified
- Date published
- 06/13/2012 verified
- Product code
- 52 A - - 36 Tumbler, drinking (container w/o handle, w/o stem & w/o foot)(Foodware/Cookware/Table | 86 L - - XQ Cup, Eye each item verified
- Product
- Glass Eye Wash Cup | Glass Eye Wash Cup each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Kenmajor Ent. Co., Date Published : 06/13/2012 Sec.5 Sinty , Taipei City, TAIWAN
— 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
52 A - - 36 Tumbler, drinking (container w/o handle, w/o stem & w/o foot)(Foodware/Cookware/Table Date Published: 06/13/2012 Desc: Glass Eye Wash Cup Notes: Class II 86 L - - XQ Cup, Eye Date Published: 06/13/2012 Desc: Glass Eye Wash Cup Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html