Ultramax Products Ltd · 89-08 · UNITED KINGDOM
For Ultramax Products 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 is Penis Pump; product code is 78 L - - KY Device, External Penile Rigidity; date published is 06/15/2010; address is Units 4-6 , Malllard Industrial Park , Wakefield, UNITED KINGDOM, verified against its source on 2026-09-16.
- Firm
- Ultramax Products 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
- Units 4-6 , Malllard Industrial Park , Wakefield, UNITED KINGDOM verified
- Date published
- 06/15/2010 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity verified
- Product
- Penis Pump verified
- FDA notes
- Class III verified
What the source says
Ultramax Products Ltd Date Published : 06/15/2010 Units 4-6 , Malllard Industrial Park , Wakefield, UNITED KINGDOM 78 L - - KY Device, External Penile Rigidity Date Published: 06/15/2010 Desc: Penis Pump Notes: Class III
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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