Reference Source

Kokkonen Ou · 89-08 · ESTONIA

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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