Smie Srl · 89-08 · ITALY
For Smie Srl · 89-08 · ITALY, 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 ITALY; product code is 85 M - - GI Aspirator, Ultrasonic; date published is 09/16/2009; address is Via Francesco Negri 15 , Casale Monferrato, Alexandria ITALY, verified against its source on 2026-09-16.
- Firm
- Smie Srl 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
- ITALY verified
- Address
- Via Francesco Negri 15 , Casale Monferrato, Alexandria ITALY verified
- Date published
- 09/16/2009 verified
- Product code
- 85 M - - GI Aspirator, Ultrasonic verified
- FDA notes
- Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/1999 verified
What the source says
Smie Srl Date Published : 09/16/2009 Via Francesco Negri 15 , Casale Monferrato, Alexandria ITALY 85 M - - GI Aspirator, Ultrasonic Date Published: 09/16/2009 Notes: Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/1999
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.