Arctic Sun Temperature Management System

System, Thermal Regulating

Medivance, Inc.

The following data is part of a premarket notification filed by Medivance, Inc. with the FDA for Arctic Sun Temperature Management System.

Pre-market Notification Details

Device IDK161602
510k NumberK161602
Device Name:Arctic Sun Temperature Management System
ClassificationSystem, Thermal Regulating
Applicant Medivance, Inc. 321 South Taylor Ave, Suite 200 Louisville,  CO  80027
ContactStacci Cronk
CorrespondentStacci Cronk
Medivance, Inc. 321 South Taylor Ave, Suite 200 Louisville,  CO  80027
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-09
Decision Date2016-09-02
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.