FCL Health Solutions Ltd · 89-08 · UNITED KINGDOM
For FCL Health Solutions Ltd, import alert is 89-08; country is UNITED KINGDOM; 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 Hyaluronic Acid; product code is 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 02/16/2018; address is Hawthorns House , Hawthorns Business Centre; Halfords Lane , Smethwick, West Midlands UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- FCL Health Solutions Ltd 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
- UNITED KINGDOM verified
- Address
- Hawthorns House , Hawthorns Business Centre; Halfords Lane , Smethwick, West Midlands UNITED KINGDOM verified
- Date published
- 02/16/2018 verified
- Product code
- 87 M - - OZ Acid, hyaluronic, intraarticular verified
- Product
- Hyaluronic Acid verified
- FDA notes
- Class III; verified
What the source says
FCL Health Solutions Ltd Date Published : 02/16/2018 Hawthorns House , Hawthorns Business Centre; Halfords Lane , Smethwick, West Midlands UNITED KINGDOM
— 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
87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 02/16/2018 Desc: Hyaluronic Acid Notes: Class III;
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html