Reference Source

Aqua Sole Company Ltd · 89-08 · CANADA

For Aqua Sole Company Ltd · 89-08 · CANADA, 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 CANADA; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Aqua Sole Company Ltd Date Published : 09/16/2009 27 Passmore Ave Unit #1 , Scarborough, ON CANADA 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.

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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