Sandona Snc · 89-08 · ITALY
For Sandona Snc, import alert is 89-08; country is ITALY; 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 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 2026-09-30.
- 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
— 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
80 H - - FS Shield, Nipple Date Published: 02/01/2017 Desc: Sterling Silver Nipple Shield Notes: Class I device without a valid 510k
— all from 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.