Aqua Sole Company Ltd · 89-08 · CANADA
For Aqua Sole Company Ltd, import alert is 89-08; country is CANADA; 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 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); date published is 09/16/2009; address is 27 Passmore Ave Unit #1 , Scarborough, ON CANADA, verified against its source on 2026-09-30.
- Firm
- Aqua Sole Company 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
- CANADA verified
- Address
- 27 Passmore Ave Unit #1 , Scarborough, ON CANADA verified
- Date published
- 09/16/2009 verified
- Product code
- 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) verified
- FDA notes
- Eye Mask or Eye Masque. verified
What the source says
Aqua Sole Company Ltd Date Published : 09/16/2009 27 Passmore Ave Unit #1 , Scarborough, ON CANADA
— 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
86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) Date Published: 09/16/2009 Notes: Eye Mask or Eye Masque.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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