STERRAD VELOCITY Biological Indictator And Reader

Indicator, Biological Sterilization Process

Advanced Sterilization Products (ASP)

The following data is part of a premarket notification filed by Advanced Sterilization Products (asp) with the FDA for Sterrad Velocity Biological Indictator And Reader.

Pre-market Notification Details

Device IDK170039
510k NumberK170039
Device Name:STERRAD VELOCITY Biological Indictator And Reader
ClassificationIndicator, Biological Sterilization Process
Applicant Advanced Sterilization Products (ASP) 33 Technology Drive Irvine,  CA  92618
ContactSun Choi
CorrespondentSun Choi
Advanced Sterilization Products (ASP) 33 Technology Drive Irvine,  CA  92618
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-05
Decision Date2017-06-20
Summary:summary

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