HotDog Temperature Management System

System, Thermal Regulating

Augustine Temperature Management

The following data is part of a premarket notification filed by Augustine Temperature Management with the FDA for Hotdog Temperature Management System.

Pre-market Notification Details

Device IDK220941
510k NumberK220941
Device Name:HotDog Temperature Management System
ClassificationSystem, Thermal Regulating
Applicant Augustine Temperature Management 7656 West 78th Street Minneapolis,  MN  55439
ContactGarrett Augustine
CorrespondentGarrett Augustine
Augustine Temperature Management 7656 West 78th Street Minneapolis,  MN  55439
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-31
Decision Date2022-09-23

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