The following data is part of a premarket notification filed by Medivance, Inc. with the FDA for Hybrid Arcticgel Pad.
| Device ID | K120849 |
| 510k Number | K120849 |
| Device Name: | HYBRID ARCTICGEL PAD |
| Classification | System, Thermal Regulating |
| Applicant | MEDIVANCE, INC. 321 SOUTH TAYLOR AVENUE SUITE 200 Louisville, CO 80027 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson MEDIVANCE, INC. 321 SOUTH TAYLOR AVENUE SUITE 200 Louisville, CO 80027 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-20 |
| Decision Date | 2012-07-20 |
| Summary: | summary |