Reference Source

Hirayama Manufacturing Corporation · 89-08 · JAPAN

For Hirayama Manufacturing Corporation · 89-08 · JAPAN, 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 JAPAN; 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 2026-09-16.

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 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

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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