Lebian International S R L · 89-08 · ARGENTINA
For Lebian International S R L, import alert is 89-08; country is ARGENTINA; 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 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 2026-09-30.
- 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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html