The following data is part of a premarket notification filed by Medtech Products Inc. with the FDA for Compound W Nitro-freeze.
| Device ID | K172373 |
| 510k Number | K172373 |
| Device Name: | Compound W Nitro-Freeze |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Medtech Products Inc. 660 White Plains Rd Suite 250 Tarrytown, NY 10591 |
| Contact | Jean Boyko |
| Correspondent | Vincent Argiro Medtech Products Inc. 660 White Plains Rd Suite 250 Tarrytown, NY 10591 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-07 |
| Decision Date | 2017-11-02 |
| Summary: | summary |