X4 Laboratories, Incorporated · 89-08 · CANADA
For X4 Laboratories, Incorporated, 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 1365 Beaumont Ave. , Cp 65511 Csp Beaumont , Mont-Royal, Quebec CANADA, verified against its source on 2026-09-30.
- Firm
- X4 Laboratories, Incorporated 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. , Cp 65511 Csp Beaumont , Mont-Royal, Quebec 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
X4 Laboratories, Incorporated Date Published : 09/20/2011 1365 Beaumont Ave. , Cp 65511 Csp Beaumont , Mont-Royal, Quebec 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.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html