WAKE SPOL. S.R.O. · 89-08 · CZECH REPUBLIC
For WAKE SPOL. S.R.O., import alert is 89-08; country is CZECH REPUBLIC; 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 Would Be Gone Wound Healing Gel; product code is 79 N - - AE Dressing, Wound, Hydrogel; date published is 11/14/2011; address is Arbesova 797/3 , Plzenske Predmesti, Plzensky CZECH REPUBLIC, verified against its source on 2026-09-30.
- Firm
- WAKE SPOL. 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
- Arbesova 797/3 , Plzenske Predmesti, Plzensky 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 SPOL. S.R.O. Date Published : 11/14/2011 Arbesova 797/3 , Plzenske Predmesti, Plzensky CZECH REPUBLIC
— 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
79 N - - AE Dressing, Wound, Hydrogel Date Published: 11/14/2011 Desc: Would Be Gone Wound Healing Gel Notes: Class I
— all from 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.