GETINGE 800HC- SERIES STEAM STERILIZER

Sterilizer, Steam

GETINGE SOURCING LLC

The following data is part of a premarket notification filed by Getinge Sourcing Llc with the FDA for Getinge 800hc- Series Steam Sterilizer.

Pre-market Notification Details

Device IDK122625
510k NumberK122625
Device Name:GETINGE 800HC- SERIES STEAM STERILIZER
ClassificationSterilizer, Steam
Applicant GETINGE SOURCING LLC 1777 EAST HENRIETTA RD. Rochester,  NY  14623 -3133
ContactBarb Smith
CorrespondentBarb Smith
GETINGE SOURCING LLC 1777 EAST HENRIETTA RD. Rochester,  NY  14623 -3133
Product CodeFLE  
CFR Regulation Number880.6880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-28
Decision Date2013-05-22
Summary:summary

NIH GUDID Devices

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