Reference Source

Hirayama Manufacturing Corporation · 89-08 · JAPAN

For Hirayama Manufacturing Corporation, 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 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use; date published is 09/16/2009; address is 216-16 , Yushima , Bunkyo, Tokyo JAPAN, verified against its source on 2026-09-30.

Firm
Hirayama Manufacturing Corporation 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
216-16 , Yushima , Bunkyo, Tokyo JAPAN verified
Date published
09/16/2009 verified
Product code
75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use verified
FDA notes
Sterilizer; Autoclave 9/17/1998 verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Hirayama Manufacturing Corporation Date Published : 09/16/2009 216-16 , Yushima , Bunkyo, 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

75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use Date Published: 09/16/2009 Notes: Sterilizer; Autoclave 9/17/1998

— 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.

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.