The following data is part of a premarket notification filed by Medivance, Inc. with the FDA for Modification To Arctic Sun Temperature Management System, Model 2000.
| Device ID | K071341 |
| 510k Number | K071341 |
| Device Name: | MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 |
| Classification | System, Thermal Regulating |
| Applicant | MEDIVANCE, INC. 1172 CENTURY DR., SUITE 240 Louisville, CO 80027 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson MEDIVANCE, INC. 1172 CENTURY DR., SUITE 240 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 | 2007-05-14 |
| Decision Date | 2007-08-03 |
| Summary: | summary |