Sandona Snc · 89-08 · ITALY
For Sandona Snc · 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 is Sterling Silver Nipple Shield; product code is 80 H - - FS Shield, Nipple; date published is 02/01/2017; address is Via Carlo Alberto 50 , Treviso, Treviso ITALY, verified against its source on 2026-09-16.
- Firm
- Sandona Snc 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 Carlo Alberto 50 , Treviso, Treviso ITALY verified
- Date published
- 02/01/2017 verified
- Product code
- 80 H - - FS Shield, Nipple verified
- Product
- Sterling Silver Nipple Shield verified
- FDA notes
- Class I device without a valid 510k verified
What the source says
Sandona Snc Date Published : 02/01/2017 Via Carlo Alberto 50 , Treviso, Treviso ITALY 80 H - - FS Shield, Nipple Date Published: 02/01/2017 Desc: Sterling Silver Nipple Shield Notes: Class I device without a valid 510k
— 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.