Reference Source

Medispec, Ltd. · 89-08 · ISRAEL

For Medispec, Ltd. · 89-08 · ISRAEL, 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 ISRAEL; product is Radialspec; product code is 89 O - - OV Evopace system and accessories; date published is 05/17/2010; address is 40, Hataasiya Street , Yehud, ISRAEL, verified against its source on 2026-09-16.

Firm
Medispec, 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
ISRAEL verified
Address
40, Hataasiya Street , Yehud, ISRAEL verified
Date published
05/17/2010 verified
Product code
89 O - - OV Evopace system and accessories verified
Product
Radialspec verified
FDA notes
Class III verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Medispec, Ltd. Date Published : 05/17/2010 40, Hataasiya Street , Yehud, ISRAEL 89 O - - OV Evopace system and accessories Date Published: 05/17/2010 Desc: Radialspec Notes: Class III

accessdata.fda.gov, retrieved 2026-09-15

Source

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