SkandiaLife Manufacturing · 89-08 · ESTONIA
For SkandiaLife Manufacturing · 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 Sybaritic Inc. (Sybaritic) Hydration Station; product code is 89 I - - MB Cabinet, Moist Steam; date published is 09/29/2009; address is Varbola Kula, Marjamaa Vald , Raplamaa, ESTONIA, verified against its source on 2026-09-16.
- Firm
- SkandiaLife Manufacturing 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
- Varbola Kula, Marjamaa Vald , Raplamaa, ESTONIA verified
- Date published
- 09/29/2009 verified
- Product code
- 89 I - - MB Cabinet, Moist Steam verified
- Product
- Sybaritic Inc. (Sybaritic) Hydration Station verified
- FDA notes
- Class II; 9/1/2009 verified
What the source says
SkandiaLife Manufacturing Date Published : 09/29/2009 Varbola Kula, Marjamaa Vald , Raplamaa, ESTONIA 89 I - - MB Cabinet, Moist Steam Date Published: 01/30/2019 Desc: Sybaritic Inc. (Sybaritic) Hydration Station Notes: Class II; 9/1/2009
— 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.