Lebian International S R L · 89-08 · ARGENTINA
For Lebian International S R L · 89-08 · ARGENTINA, 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 ARGENTINA; product is Gynecological devices (Small #2; Medium #3; Large #4); product code is 85 H - - -- Portion of device code; date published is 05/16/2014; address is Calle La Paz 1071 , Rosario, Santa Fe ARGENTINA, verified against its source on 2026-09-16.
- Firm
- Lebian International S R L 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
- ARGENTINA verified
- Address
- Calle La Paz 1071 , Rosario, Santa Fe ARGENTINA verified
- Date published
- 05/16/2014 verified
- Product code
- 85 H - - -- Portion of device code verified
- Product
- Gynecological devices (Small #2; Medium #3; Large #4) verified
- FDA notes
- Autoexpandable and Discardable Speculum for Gynecological Use Models verified
What the source says
Lebian International S R L Date Published : 05/16/2014 Calle La Paz 1071 , Rosario, Santa Fe ARGENTINA 85 H - - -- Portion of device code Date Published: 05/16/2014 Desc: Gynecological devices (Small #2; Medium #3; Large #4) Notes: Autoexpandable and Discardable Speculum for Gynecological Use Models
— 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.