Nouvag Ag · 89-08 · SWITZERLAND
For Nouvag Ag · 89-08 · SWITZERLAND, 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 SWITZERLAND; 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 2026-09-16.
- 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 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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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