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
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
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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