The following data is part of a premarket notification filed by Medtech Products Inc. with the FDA for Compound W Wart Removal System Dual Power.
| Device ID | K161294 |
| 510k Number | K161294 |
| Device Name: | Compound W Wart Removal System Dual Power |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | MEDTECH PRODUCTS INC. 660 WHITE PLAINS ROAD Tarrytown, NY 10591 |
| Contact | Jean Boyko |
| Correspondent | Kathryn A. Coressel EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVE SUITE 1400 Austin, TX 78701 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-05-09 |
| Decision Date | 2016-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075137110854 | K161294 | 000 |