STERRAD 50 STERILIZER

Sterilizer, Chemical

ADVANCED STERILIZATION PRODUCTS

The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad 50 Sterilizer.

Pre-market Notification Details

Device IDK981625
510k NumberK981625
Device Name:STERRAD 50 STERILIZER
ClassificationSterilizer, Chemical
Applicant ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine,  CA  92618
ContactKevin Corrigan
CorrespondentKevin Corrigan
ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine,  CA  92618
Product CodeMLR  
CFR Regulation Number880.6860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-07
Decision Date1999-01-11
Summary:summary

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