WART FREEZE
Unit, Cryosurgical, Accessories
KONINKLIJKE UTERMOHLEN NV
The following data is part of a premarket notification filed by Koninklijke Utermohlen Nv with the FDA for Wart Freeze.
Pre-market Notification Details
| Device ID | K101049 |
| 510k Number | K101049 |
| Device Name: | WART FREEZE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | KONINKLIJKE UTERMOHLEN NV 4 INNOVATION DRIVE Dundas, Ontario, CA L9h 7p3 |
| Contact | Shirley Furesz |
| Correspondent | Shirley Furesz KONINKLIJKE UTERMOHLEN NV 4 INNOVATION DRIVE Dundas, Ontario, CA L9h 7p3 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-14 |
| Decision Date | 2011-06-23 |
| Summary: | summary |
Trademark Results [WART FREEZE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WART FREEZE 77318354 not registered Dead/Abandoned |
OraSure Technologies, Inc. 2007-10-31 |
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