R. OH Canada · 89-08 · CANADA

For R. OH Canada, import alert is 89-08; country is CANADA; 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 is Any Penile Corrective Devices | Any Penile Corrective Devices; product code is 78 L - - -- Portion of device code | 78 N - - -- Portion of device code; date published is 09/20/2011; address is listed twice: 1365 Beaumont Ave. , Po Box 65511 , Montreal, Alberta CANADA and 6855 De L'Epee Avefloor: 3 Unit: 302 , Montrealmontreal, QUEBEC CANADA, verified against its source on 2026-09-30.

What the source says

R. OH Canada Date Published : 09/20/2011 1365 Beaumont Ave. , Po Box 65511 , Montreal, Alberta CANADA

— 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.

— all from accessdata.fda.gov, retrieved 2026-09-15

The same source also states

R. Oh Canada Date Published : 09/20/2011 6855 De L'Epee Avefloor: 3 Unit: 302 , Montrealmontreal, QUEBEC CANADA

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

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.