STERILUCENT PROCESS CHALLENGE DEVICE

Indicator, Biological Sterilization Process

STERILUCENT, INC

The following data is part of a premarket notification filed by Sterilucent, Inc with the FDA for Sterilucent Process Challenge Device.

Pre-market Notification Details

Device IDK141312
510k NumberK141312
Device Name:STERILUCENT PROCESS CHALLENGE DEVICE
ClassificationIndicator, Biological Sterilization Process
Applicant STERILUCENT, INC 1400 MARSHALL STREET NE Minneapolis,  MN  55413
ContactPeter Kalkbrenner
CorrespondentPeter Kalkbrenner
STERILUCENT, INC 1400 MARSHALL STREET NE Minneapolis,  MN  55413
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-20
Decision Date2014-10-31
Summary:summary

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