Reference Source

Medica Outlet · 89-08 · CANADA

For Medica Outlet · 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 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 2026-09-16.

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 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.

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

Source

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