Hang&Go PAC

Warmer, Thermal, Infusion Fluid

RanD S.r.l.

The following data is part of a premarket notification filed by Rand S.r.l. with the FDA for Hang&go Pac.

Pre-market Notification Details

Device IDK161613
510k NumberK161613
Device Name:Hang&Go PAC
ClassificationWarmer, Thermal, Infusion Fluid
Applicant RanD S.r.l. via Statale 12, 62 Medolla,  IT 41036
ContactSimone Ceretti
CorrespondentSimone Ceretti
RanD S.r.l. via Statale 12, 62 Medolla,  IT 41036
Product CodeLGZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-10
Decision Date2016-12-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M640R99001170001 K161613 000
M640R99001170011 K161613 000
M640R99001170021 K161613 000
M640R99001170031 K161613 000

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