The following data is part of a premarket notification filed by Medivance, Inc. with the FDA for Arctic Sun Temperature Management System.
| Device ID | K161602 |
| 510k Number | K161602 |
| Device Name: | Arctic Sun Temperature Management System |
| Classification | System, Thermal Regulating |
| Applicant | Medivance, Inc. 321 South Taylor Ave, Suite 200 Louisville, CO 80027 |
| Contact | Stacci Cronk |
| Correspondent | Stacci Cronk Medivance, Inc. 321 South Taylor Ave, Suite 200 Louisville, CO 80027 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-09 |
| Decision Date | 2016-09-02 |
| Summary: | summary |