Hydrozid
Unit, Cryosurgical, Accessories
MediLink A/S
The following data is part of a premarket notification filed by Medilink A/s with the FDA for Hydrozid.
Pre-market Notification Details
| Device ID | K201740 |
| 510k Number | K201740 |
| Device Name: | Hydrozid |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | MediLink A/S Gammelmosevej 176A Kgs. Lyngby, DK 2800 |
| Contact | Cristina Teixeira |
| Correspondent | Cristina Teixeira MediLink A/S Gammelmosevej 176A Kgs. Lyngby, DK 2800 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-25 |
| Decision Date | 2021-07-07 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05744002420033 | K201740 | 000 |
Trademark Results [Hydrozid]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYDROZID 88001926 not registered Live/Pending |
Doc-Bibawo ApS 2018-06-15 |
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