Reference Source

Firma Dinamika Llc. Co. · 89-08 · RUSSIA

For Firma Dinamika Llc. Co., import alert is 89-08; country is RUSSIA; 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 Fralov's Respiration Training Devices; product code is 80 N - - ZJ Respirator, n95, home use; date published is 03/31/2013; address is 1-y Parkhomenko Per 14 , Novosibirsk, Novosibirskaya obl RUSSIA, verified against its source on 2026-09-30.

Firm
Firma Dinamika Llc. 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
RUSSIA verified
Address
1-y Parkhomenko Per 14 , Novosibirsk, Novosibirskaya obl RUSSIA verified
Date published
03/31/2013 verified
Product code
80 N - - ZJ Respirator, n95, home use verified
Product
Fralov's Respiration Training Devices 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

Firma Dinamika Llc. Co. Date Published : 03/31/2013 1-y Parkhomenko Per 14 , Novosibirsk, Novosibirskaya obl RUSSIA

— 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 N - - ZJ Respirator, n95, home use Date Published: 03/31/2013 Desc: Fralov's Respiration Training Devices Notes: Class II

— all from 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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