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