Puretone Ltd. · 89-08 · UNITED KINGDOM
For Puretone Ltd. · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; 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 2026-09-16.
- 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 77 K - - LW Masker, Tinnitis Date Published: 09/16/2009 Notes: 7/15/2009 Tinnitus Maskers
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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