The following data is part of a premarket notification filed by Medivance, Inc. with the FDA for Arctic Sun Temperature Management System, Model 5000.
| Device ID | K101092 |
| 510k Number | K101092 |
| Device Name: | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 |
| Classification | System, Thermal Regulating |
| Applicant | MEDIVANCE, INC. 321 SOUTH TAYLOR AVE, STE 200 Louisville, CO 80027 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson MEDIVANCE, INC. 321 SOUTH TAYLOR AVE, STE 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 | 2010-04-20 |
| Decision Date | 2010-07-16 |
| Summary: | summary |