Ark Bio Medical Canada Corp · 89-08 · CANADA
For Ark Bio Medical Canada Corp · 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 Ark Bio Microwave Plasma Defroster; product code is 81 K - - ZL Device, Warming, Blood and Plasma; date published is 10/07/2016; address is 671 Rustico Rd - Rte 7 , North Milton, Prince Edward Island CANADA, verified against its source on 2026-09-16.
- Firm
- Ark Bio Medical Canada Corp 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
- 671 Rustico Rd - Rte 7 , North Milton, Prince Edward Island CANADA verified
- Date published
- 10/07/2016 verified
- Product code
- 81 K - - ZL Device, Warming, Blood and Plasma verified
- Product
- Ark Bio Microwave Plasma Defroster verified
What the source says
Ark Bio Medical Canada Corp Date Published : 10/07/2016 671 Rustico Rd - Rte 7 , North Milton, Prince Edward Island CANADA 81 K - - ZL Device, Warming, Blood and Plasma Date Published: 10/07/2016 Desc: Ark Bio Microwave Plasma Defroster
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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