The following data is part of a premarket notification filed by Wartner Usa B.v. with the FDA for Wartner Wart Removal System, Model 66715 82000 (product Code Number 52e022).
| Device ID | K032271 |
| 510k Number | K032271 |
| Device Name: | WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | WARTNER USA B.V. 65 AVA CRESCENT Richmond Hill, Ontario, CA L4b 2x5 |
| Contact | Nancy Lum-wilson |
| Correspondent | Nancy Lum-wilson WARTNER USA B.V. 65 AVA CRESCENT Richmond Hill, Ontario, CA L4b 2x5 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-23 |
| Decision Date | 2003-09-10 |
| Summary: | summary |