CryoVIVE
Unit, Cryosurgical, Accessories
Recens Medical Inc.
The following data is part of a premarket notification filed by Recens Medical Inc. with the FDA for Cryovive.
Pre-market Notification Details
| Device ID | K203481 |
| 510k Number | K203481 |
| Device Name: | CryoVIVE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Recens Medical Inc. 908, SK V1 Center, 830 Dongtansunhwan-daero Hwaseong-si, KR 18468 |
| Contact | Yeonui Lee |
| Correspondent | Dave Kim Mtech Group 7707 Fannin Street Ste 200-V111 Houston, TX 77054 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-27 |
| Decision Date | 2021-05-13 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800073100018 | K203481 | 000 |
Trademark Results [CryoVIVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRYOVIVE 90166666 not registered Live/Pending |
RecensMedical.Inc. 2020-09-08 |
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