Reference Source

Medica Outlet · 89-08 · CANADA

For Medica Outlet, 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 is Teosyal; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use; date published is 06/11/2015; address is Toronto Eaton Centre , 1 Dundas St W Suite 2601 , Toronto, Ontario CANADA, verified against its source on 2026-09-30.

Firm
Medica Outlet 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
Toronto Eaton Centre , 1 Dundas St W Suite 2601 , Toronto, Ontario CANADA verified
Date published
06/11/2015 verified
Product code
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use verified
Product
Teosyal verified
FDA notes
Class III. Teosyal is a dermal filler intended for treating wrinkles; adding contour to facial features; enhancing the lips and eliminating the appearance of aging. The product is marketed on www.medicaoutlet.com. verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Medica Outlet Date Published : 06/11/2015 Toronto Eaton Centre , 1 Dundas St W Suite 2601 , Toronto, Ontario 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, Product and FDA notes

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 06/11/2015 Desc: Teosyal Notes: Class III. Teosyal is a dermal filler intended for treating wrinkles; adding contour to facial features; enhancing the lips and eliminating the appearance of aging. The product is marketed on www.medicaoutlet.com.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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