The following data is part of a premarket notification filed by Koninklijke Utermohlen Nv with the FDA for Wart Freeze.
| Device ID | K130599 |
| 510k Number | K130599 |
| Device Name: | WART FREEZE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | KONINKLIJKE UTERMOHLEN NV 11956 BERNARDO PLAZA DR. #417 San Diego, CA 92128 -1317 |
| Contact | Kenneth R Michael |
| Correspondent | Kenneth R Michael KONINKLIJKE UTERMOHLEN NV 11956 BERNARDO PLAZA DR. #417 San Diego, CA 92128 -1317 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-07 |
| Decision Date | 2013-06-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() WART FREEZE 77318354 not registered Dead/Abandoned |
OraSure Technologies, Inc. 2007-10-31 |