Camilla Noenygaard · 89-08 · DENMARK
For Camilla Noenygaard, import alert is 89-08; country is DENMARK; 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 Penile Extender | Penile Extender; product code is 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical; date published is 06/08/2011; address is Maglebjergvej 4 , Kgs Lyngby, DENMARK, verified against its source on 2026-09-30.
- Firm
- Camilla Noenygaard 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
- DENMARK verified
- Address
- Maglebjergvej 4 , Kgs Lyngby, DENMARK verified
- Date published
- 06/08/2011 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical each item verified
- Product
- Penile Extender | Penile Extender each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Camilla Noenygaard Date Published : 06/08/2011 Maglebjergvej 4 , Kgs Lyngby, DENMARK
— 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 - - KY Device, External Penile Rigidity Date Published: 06/08/2011 Desc: Penile Extender Notes: Class II 78 N - - HU Extender, Penile, Mechanical Date Published: 06/08/2011 Desc: Penile Extender Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html