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 |