VitriGuard
Labware, Assisted Reproduction
ORIGIO A/s
The following data is part of a premarket notification filed by Origio A/s with the FDA for Vitriguard.
Pre-market Notification Details
| Device ID | K200815 |
| 510k Number | K200815 |
| Device Name: | VitriGuard |
| Classification | Labware, Assisted Reproduction |
| Applicant | ORIGIO A/s Knardrupvej 2 Malov, DK 2760 |
| Contact | Christine Kupchick |
| Correspondent | Christine Kupchick CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-30 |
| Decision Date | 2020-06-25 |
Trademark Results [VitriGuard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITRIGUARD 87042270 5381454 Live/Registered |
Origio A/S 2016-05-18 |
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