GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)

System, Thermal Regulating

RG ENT., INC.

The following data is part of a premarket notification filed by Rg Ent., Inc. with the FDA for Geratherm Sos-vacutherm (thermamed Smartcare).

Pre-market Notification Details

Device IDK051278
510k NumberK051278
Device Name:GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
ClassificationSystem, Thermal Regulating
Applicant RG ENT., INC. 21130 BRIDGE STREET Southfield,  MI  48034
ContactRonald G Letourneau
CorrespondentRonald G Letourneau
RG ENT., INC. 21130 BRIDGE STREET Southfield,  MI  48034
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-17
Decision Date2006-06-29
Summary:summary

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