Hemcon Medical Technologies Europe, Ltd. · 89-08 · IRELAND
For Hemcon Medical Technologies Europe, Ltd., import alert is 89-08; country is IRELAND; 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 Splint; Intranasal Septal; product code is 77 L - - YA Splint, Intranasal Septal; date published is 09/08/2015; address is Blackrocks , 515 Orwell Park Way , Dublin 6w, Co. DUBLIN IRELAND, verified against its source on 2026-09-30.
- Firm
- Hemcon Medical Technologies Europe, 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
- IRELAND verified
- Address
- Blackrocks , 515 Orwell Park Way , Dublin 6w, Co. DUBLIN IRELAND verified
- Date published
- 09/08/2015 verified
- Product code
- 77 L - - YA Splint, Intranasal Septal verified
- Product
- Splint; Intranasal Septal verified
- FDA notes
- Class I; Synaero verified
What the source says
Hemcon Medical Technologies Europe, Ltd. Date Published : 09/08/2015 Blackrocks , 515 Orwell Park Way , Dublin 6w, Co. DUBLIN IRELAND
— 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
77 L - - YA Splint, Intranasal Septal Date Published: 09/08/2015 Desc: Splint; Intranasal Septal Notes: Class I; Synaero
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html