SteriTrak
Component, Traction, Invasive
Arbutus Medical Inc.
The following data is part of a premarket notification filed by Arbutus Medical Inc. with the FDA for Steritrak.
Pre-market Notification Details
| Device ID | K203605 |
| 510k Number | K203605 |
| Device Name: | SteriTrak |
| Classification | Component, Traction, Invasive |
| Applicant | Arbutus Medical Inc. 828 10th Ave W, Suite 560 Vancouver, CA V5z 1l8 |
| Contact | Michael Cancilla |
| Correspondent | Michael Cancilla Arbutus Medical Inc. 828 10th Ave W, Suite 560 Vancouver, CA V5z 1l8 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-10 |
| Decision Date | 2021-04-23 |
Trademark Results [SteriTrak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERITRAK 90185233 not registered Live/Pending |
Arbutus Medical Inc. 2020-09-16 |
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