# Kokkonen Ou · 89-08 · ESTONIA — FDA import alert red lists: firms subject to detention without physical examination

For Kokkonen Ou · 89-08 · ESTONIA, 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 ESTONIA; 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 2026-09-16.

- **Firm:** Kokkonen Ou _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Kasvu 16-18 , Tallinn, Harju ESTONIA _(verified: appears in the quote below)_
- **Date published:** 01/21/2014 _(verified: appears in the quote below)_
- **Product code:** 80 - - - -- General Hospital/Personal Use _(verified: appears in the quote below)_
- **Product:** Saltarium Salt Cocoon _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Kokkonen Ou Date Published : 01/21/2014 Kasvu 16-18 , Tallinn, Harju ESTONIA 80 - - - -- General Hospital/Personal Use Date Published: 11/08/2018 Desc: Saltarium Salt Cocoon Notes: Class II

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).