Nouvag Ag · 89-08 · SWITZERLAND
For Nouvag Ag, import alert is 89-08; country is SWITZERLAND; 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 Liposuction Machine; LipoSurg | Liposuction Machine; LipoSurg | Liposuction Machine; LipoSurg; product code is 79 J - - CX Apparatus, Suction, Ward Use, Portable, Ac-Powered | 79 M - - UU System, Suction, Lipoplasty | 80 F - - RN Pump, Infusion; date published is 08/14/2019; address is St. Gallerstrasse 23-25 , Goldach, St. Gallen SWITZERLAND, verified against its source on 2026-09-30.
- Firm
- Nouvag Ag 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
- SWITZERLAND verified
- Address
- St. Gallerstrasse 23-25 , Goldach, St. Gallen SWITZERLAND verified
- Date published
- 08/14/2019 verified
- Product code
- 79 J - - CX Apparatus, Suction, Ward Use, Portable, Ac-Powered | 79 M - - UU System, Suction, Lipoplasty | 80 F - - RN Pump, Infusion each item verified
- Product
- Liposuction Machine; LipoSurg | Liposuction Machine; LipoSurg | Liposuction Machine; LipoSurg each item verified
- FDA notes
- Class II device, requires 510(k), or de novo application. | Class II device, requires 510(k), or de novo application. | Class II device, requires 510(k), or de novo application. each item verified
What the source says
Nouvag Ag Date Published : 08/14/2019 St. Gallerstrasse 23-25 , Goldach, St. Gallen SWITZERLAND
— 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
79 J - - CX Apparatus, Suction, Ward Use, Portable, Ac-Powered Date Published: 11/21/2024 Desc: Liposuction Machine; LipoSurg Notes: Class II device, requires 510(k), or de novo application. 79 M - - UU System, Suction, Lipoplasty Date Published: 11/21/2024 Desc: Liposuction Machine; LipoSurg Notes: Class II device, requires 510(k), or de novo application. 80 F - - RN Pump, Infusion Date Published: 11/21/2024 Desc: Liposuction Machine; LipoSurg Notes: Class II device, requires 510(k), or de novo application.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html