Binder International · 89-08 · GERMANY
For Binder International, import alert is 89-08; country is GERMANY; 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 code is 84 H - - CC Device, Biofeedback; date published is 09/16/2009; address is Otto-Hahn-Str. 19 , Herrenberg, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-30.
- Firm
- Binder International 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
- GERMANY verified
- Address
- Otto-Hahn-Str. 19 , Herrenberg, Baden-Wurttemberg GERMANY verified
- Date published
- 09/16/2009 verified
- Product code
- 84 H - - CC Device, Biofeedback verified
- FDA notes
- Ondamned System Regulation (Biofeedback Device) 4/29/2003 Lack of 510(k) Approval. verified
What the source says
Binder International Date Published : 09/16/2009 Otto-Hahn-Str. 19 , Herrenberg, Baden-Wurttemberg GERMANY
— 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 and FDA notes
84 H - - CC Device, Biofeedback Date Published: 09/16/2009 Notes: Ondamned System Regulation (Biofeedback Device) 4/29/2003 Lack of 510(k) Approval.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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