Reference Source

Fuji Latex Co., Ltd. · 89-08 · JAPAN

For Fuji Latex Co., Ltd., import alert is 89-08; country is JAPAN; 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 85 H - - IS Condom; date published is 09/16/2009; address is 150 Ko-Machi , Tokyo, JAPAN, verified against its source on 2026-09-30.

Firm
Fuji Latex Co., Ltd. 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
JAPAN verified
Address
150 Ko-Machi , Tokyo, JAPAN verified
Date published
09/16/2009 verified
Product code
85 H - - IS Condom verified
FDA notes
Wrinkle Chapeau Condoms. 7/20/1993 verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Fuji Latex Co., Ltd. Date Published : 09/16/2009 150 Ko-Machi , Tokyo, JAPAN

— 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

85 H - - IS Condom Date Published: 09/16/2009 Notes: Wrinkle Chapeau Condoms. 7/20/1993

— all from 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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