The following data is part of a premarket notification filed by Medivance, Inc. with the FDA for Arctic Sun Temperature Management System, Arcticgel Pads (universal, Xxs, Xs, S, M And L), Small Universal Arcticgel Pad, Neonatal Arcticgel Pad.
| Device ID | K142702 |
| 510k Number | K142702 |
| Device Name: | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M And L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad |
| Classification | System, Thermal Regulating |
| Applicant | MEDIVANCE, INC. 321 SOUTH TAYLOR AVENUE SUITE 200 Louisville, CO 80027 |
| Contact | Stacci Cronk |
| Correspondent | Stacci Cronk 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 | 2014-09-22 |
| Decision Date | 2014-12-18 |
| Summary: | summary |