The following data is part of a premarket notification filed by Yonmedical Bv with the FDA for Wartie Wart Remover.
| Device ID | K140314 |
| 510k Number | K140314 |
| Device Name: | WARTIE WART REMOVER |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | YONMEDICAL BV PO BOX 2042 Fairfield, IA 52556 |
| Contact | Kathleen Johnson |
| Correspondent | Kathleen Johnson YONMEDICAL BV PO BOX 2042 Fairfield, IA 52556 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-10 |
| Decision Date | 2014-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075137108257 | K140314 | 000 |