Incosmo S.R.L · 89-08 · ITALY
For Incosmo S.R.L, 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 Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant; product code is 80 K - - MJ Lubricant, Patient | 80 M - - MS Lubricant, Vaginal, Patient | 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible; date published is 03/20/2018; address is Via I Maggio 7 , Biassono, Monza E della Brianza ITALY, verified against its source on 2026-09-30.
- Firm
- Incosmo 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
- ITALY verified
- Address
- Via I Maggio 7 , Biassono, Monza E della Brianza ITALY verified
- Date published
- 03/20/2018 verified
- Product code
- 80 K - - MJ Lubricant, Patient | 80 M - - MS Lubricant, Vaginal, Patient | 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible each item verified
- Product
- Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant each item verified
What the source says
Incosmo S.R.L Date Published : 03/20/2018 Via I Maggio 7 , Biassono, Monza E della Brianza 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 and Product
80 K - - MJ Lubricant, Patient Date Published: 03/20/2018 Desc: Long-Lasting Personal Lubricant 80 M - - MS Lubricant, Vaginal, Patient Date Published: 03/20/2018 Desc: Long-Lasting Personal Lubricant 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible Date Published: 03/20/2018 Desc: Long-Lasting Personal Lubricant
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html