CryoTreQ
Unit, Cryophthalmic
VitreQ B.V.
The following data is part of a premarket notification filed by Vitreq B.v. with the FDA for Cryotreq.
Pre-market Notification Details
| Device ID | K202038 |
| 510k Number | K202038 |
| Device Name: | CryoTreQ |
| Classification | Unit, Cryophthalmic |
| Applicant | VitreQ B.V. Segglant-Noord 2 Vierpolders, NL 3237mg |
| Contact | Christian Neele |
| Correspondent | Debora Stapleton Dynamic Strategies Inc. 25 Granite Street Medway, MA 02053 |
| Product Code | HPS |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-23 |
| Decision Date | 2020-12-30 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719214223458 | K202038 | 000 |
Trademark Results [CryoTreQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRYOTREQ 79269178 not registered Live/Pending |
Vitreq B.V. 2019-08-14 |
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