Reference Source

SAPP · 89-08 · FRANCE

For SAPP · 89-08 · FRANCE, 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 FRANCE; product code is 76 M - - GE Hearing-Aid, Audiodontic; date published is 09/16/2009; address is 4 rue Cozette , Amiens, Somme FRANCE, verified against its source on 2026-09-16.

Firm
SAPP 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
FRANCE verified
Address
4 rue Cozette , Amiens, Somme FRANCE verified
Date published
09/16/2009 verified
Product code
76 M - - GE Hearing-Aid, Audiodontic verified
FDA notes
Audiokinetron Device. 3/29/1994. verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

SAPP Date Published : 09/16/2009 4 rue Cozette , Amiens, Somme FRANCE 76 M - - GE Hearing-Aid, Audiodontic Date Published: 09/16/2009 Notes: Audiokinetron Device. 3/29/1994.

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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