The following data is part of a premarket notification filed by Occam Design with the FDA for Ouchless Model Pn10114.
| Device ID | K093951 |
| 510k Number | K093951 |
| Device Name: | OUCHLESS MODEL PN10114 |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | OCCAM DESIGN 1044 EAST CHESTNUT ST. Louisville, KY 40204 |
| Contact | Vas Abramov |
| Correspondent | Vas Abramov OCCAM DESIGN 1044 EAST CHESTNUT ST. Louisville, KY 40204 |
| Product Code | MLY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-06-15 |