X4 Labs Inc. · 89-08 · CANADA
For X4 Labs Inc. · 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 | X4 Penile corrective device | Any Penile Corrective Devices; product code is 78 L - - KY Device, External Penile Rigidity | 78 L - - -- Portion of device code | 78 N - - -- Portion of device code | 78 N - - -- Portion of device code; date published is 09/16/2009; address is 6855 De L'Epee Ave. , Montreal, QC CANADA, verified against its source on 2026-09-16.
- Firm
- X4 Labs Inc. 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
- 6855 De L'Epee Ave. , Montreal, QC CANADA verified
- Date published
- 09/16/2009 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity | 78 L - - -- Portion of device code | 78 N - - -- Portion of device code | 78 N - - -- Portion of device code each item verified
- Product
- Any Penile Corrective Devices | X4 Penile corrective device | Any Penile Corrective Devices each item verified
- FDA notes
- x4 Penile corrective device. 9/16/2008 | Class III | 9/16/2008 | Class III each item verified
What the source says
X4 Labs Inc. Date Published : 09/16/2009 6855 De L'Epee Ave. , Montreal, QC CANADA 78 L - - KY Device, External Penile Rigidity Date Published: 09/16/2009 Notes: x4 Penile corrective device. 9/16/2008 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: 09/06/2024 Desc: X4 Penile corrective device Notes: 9/16/2008 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
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