GERATHERM SOS-RESCUE BAG

System, Thermal Regulating

R.G. ENTERPRISES, INC.

The following data is part of a premarket notification filed by R.g. Enterprises, Inc. with the FDA for Geratherm Sos-rescue Bag.

Pre-market Notification Details

Device IDK051336
510k NumberK051336
Device Name:GERATHERM SOS-RESCUE BAG
ClassificationSystem, Thermal Regulating
Applicant R.G. ENTERPRISES, INC. 21130 BRIDGE STREET Southfield,  MI  48034
ContactRonald G Letoutneau
CorrespondentRonald G Letoutneau
R.G. ENTERPRISES, INC. 21130 BRIDGE STREET Southfield,  MI  48034
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-23
Decision Date2006-06-29
Summary:summary

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