The following data is part of a premarket notification filed by Vitreq B.v. with the FDA for Cryotreq.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08719214223458 | K202038 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRYOTREQ 79269178 not registered Live/Pending |
Vitreq B.V. 2019-08-14 |