Reference Source

Biotronics Research Corporation · 89-08 · CANADA

For Biotronics Research Corporation · 89-08 · CANADA, 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 CANADA; product is Bone Growth Stimulator | Bone Growth Stimulator; product code is 87 L - - OE Stimulator, invasive bone growth | 87 L - - OF Stimulator, bone growth, non-invasive; date published is 09/16/2009; address is 1104-3760 Albert Street , Burnaby, BC CANADA, verified against its source on 2026-09-16.

Firm
Biotronics Research 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
CANADA verified
Address
1104-3760 Albert Street , Burnaby, BC CANADA verified
Date published
09/16/2009 verified
Product code
87 L - - OE Stimulator, invasive bone growth | 87 L - - OF Stimulator, bone growth, non-invasive each item verified
Product
Bone Growth Stimulator | Bone Growth Stimulator each item verified
FDA notes
Class III; 10/28/2005 | Class III; 10/28/2005 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Biotronics Research Corporation Date Published : 09/16/2009 1104-3760 Albert Street , Burnaby, BC CANADA 87 L - - OE Stimulator, invasive bone growth Date Published: 01/23/2019 Desc: Bone Growth Stimulator Notes: Class III; 10/28/2005 87 L - - OF Stimulator, bone growth, non-invasive Date Published: 01/23/2019 Desc: Bone Growth Stimulator Notes: Class III; 10/28/2005

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

Source

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