The following data is part of a premarket notification filed by Youmedical Corp Bv with the FDA for Wartie Advanced Wart Remover Or Other Proprietary Name.
| Device ID | K151309 |
| 510k Number | K151309 |
| Device Name: | Wartie Advanced Wart Remover Or Other Proprietary Name |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | YOUMEDICAL CORP BV RIJNSBURGSTRAAT 9-11 Amsterdam, NL 1059 At |
| Contact | Francesca Mappa |
| Correspondent | Kathleen Johnson MEDICAL DEVICE APPROVALS, INC. PO BOX 1124 Bryn Mawr, PA 19010 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2015-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075137110571 | K151309 | 000 |