Firma Dinamika Llc. Co. · 89-08 · RUSSIA
For Firma Dinamika Llc. Co. · 89-08 · RUSSIA, 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 RUSSIA; 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 2026-09-16.
- 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 80 N - - ZJ Respirator, n95, home use Date Published: 03/31/2013 Desc: Fralov's Respiration Training Devices Notes: Class II
— 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.