R. OH Canada · 89-08 · CANADA
For R. OH Canada · 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 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 1365 Beaumont Ave. , Po Box 65511 , Montreal, Alberta CANADA, verified against its source on 2026-09-16.
- Firm
- R. OH Canada 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
- 1365 Beaumont Ave. , Po Box 65511 , Montreal, Alberta CANADA verified
- Date published
- 09/20/2011 verified
- Product code
- 78 L - - -- Portion of device code | 78 N - - -- Portion of device code each item verified
- Product
- Any Penile Corrective Devices | Any Penile Corrective Devices each item verified
- FDA notes
- Class III | Class III each item verified
What the source says
R. OH Canada Date Published : 09/20/2011 1365 Beaumont Ave. , Po Box 65511 , Montreal, Alberta CANADA 78 L - - -- Portion of device code Date Published: 09/20/2011 Desc: Any Penile Corrective Devices Notes: Class III 78 N - - -- Portion of device code Date Published: 09/20/2011 Desc: Any Penile Corrective Devices Notes: Class III
— 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 78 L - - -- Portion of device code Date Published: 09/20/2011 Desc: Any Penile Corrective Devices Notes: Class III 78 N - - -- Portion of device code Date Published: 09/20/2011 Desc: Any Penile Corrective Devices Notes: Class III
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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.