Puretone Ltd. · 89-08 · UNITED KINGDOM
For Puretone 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 code is 77 K - - LW Masker, Tinnitis; date published is 09/16/2009; address is Unit 9-10 , Henley Business Park; Trident Close , Rochester, Kent UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- Puretone 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
- Unit 9-10 , Henley Business Park; Trident Close , Rochester, Kent UNITED KINGDOM verified
- Date published
- 09/16/2009 verified
- Product code
- 77 K - - LW Masker, Tinnitis verified
- FDA notes
- 7/15/2009 Tinnitus Maskers verified
What the source says
Puretone Ltd. Date Published : 09/16/2009 Unit 9-10 , Henley Business Park; Trident Close , Rochester, Kent 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 and FDA notes
77 K - - LW Masker, Tinnitis Date Published: 09/16/2009 Notes: 7/15/2009 Tinnitus Maskers
— 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.