Wake Pharma S.R.O. · 89-08 · CZECH REPUBLIC
For Wake Pharma S.R.O. · 89-08 · CZECH REPUBLIC, 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 CZECH REPUBLIC; product is Would Be Gone Wound Healing Gel; product code is 79 N - - AE Dressing, Wound, Hydrogel; date published is 11/14/2011; address is Srobarova 1869/14 , 10 , Prague 101, None of the above CZECH REPUBLIC, verified against its source on 2026-09-16.
- Firm
- Wake Pharma S.R.O. 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
- CZECH REPUBLIC verified
- Address
- Srobarova 1869/14 , 10 , Prague 101, None of the above CZECH REPUBLIC verified
- Date published
- 11/14/2011 verified
- Product code
- 79 N - - AE Dressing, Wound, Hydrogel verified
- Product
- Would Be Gone Wound Healing Gel verified
- FDA notes
- Class I verified
What the source says
Wake Pharma S.R.O. Date Published : 11/14/2011 Srobarova 1869/14 , 10 , Prague 101, None of the above CZECH REPUBLIC 79 N - - AE Dressing, Wound, Hydrogel Date Published: 11/14/2011 Desc: Would Be Gone Wound Healing Gel Notes: Class I
— 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.