Kokkonen Ou · 89-08 · ESTONIA
For Kokkonen Ou, import alert is 89-08; country is ESTONIA; 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 Saltarium Salt Cocoon; product code is 80 - - - -- General Hospital/Personal Use; date published is 01/21/2014; address is Kasvu 16-18 , Tallinn, Harju ESTONIA, verified against its source on 2026-09-30.
- Firm
- Kokkonen Ou 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
- ESTONIA verified
- Address
- Kasvu 16-18 , Tallinn, Harju ESTONIA verified
- Date published
- 01/21/2014 verified
- Product code
- 80 - - - -- General Hospital/Personal Use verified
- Product
- Saltarium Salt Cocoon verified
- FDA notes
- Class II verified
What the source says
Kokkonen Ou Date Published : 01/21/2014 Kasvu 16-18 , Tallinn, Harju ESTONIA
— 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
80 - - - -- General Hospital/Personal Use Date Published: 11/08/2018 Desc: Saltarium Salt Cocoon 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
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.