TargetCool
Unit, Cryosurgical, Accessories
RecensMedical Inc.
The following data is part of a premarket notification filed by Recensmedical Inc. with the FDA for Targetcool.
Pre-market Notification Details
| Device ID | K221234 |
| 510k Number | K221234 |
| Device Name: | TargetCool |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | RecensMedical Inc. 908, SK V1 Center, 830 Dongtansunhwan-daero Hwaseong-si, KR 18468 |
| Contact | Yeonui Lee |
| Correspondent | Yeonui Lee RecensMedical Inc. 908, SK V1 Center, 830 Dongtansunhwan-daero Hwaseong-si, KR 18468 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-29 |
| Decision Date | 2022-07-22 |
Trademark Results [TargetCool]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TARGETCOOL 97139599 not registered Live/Pending |
RecensMedical.Inc. 2021-11-23 |
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