HotDog Temperature Management Controller

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 Controller.

Pre-market Notification Details

Device IDK201779
510k NumberK201779
Device Name:HotDog Temperature Management Controller
ClassificationSystem, Thermal Regulating
Applicant Augustine Temperature Management 7656 West 78th Street Minneapolis,  MN  55439
ContactTemi Ogunse
CorrespondentTemi Ogunse
Augustine Temperature Management 7656 West 78th Street Minneapolis,  MN  55439
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-30
Decision Date2020-09-11

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