STERRAD 100NX 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 100nx Sterilizer.

Pre-market Notification Details

Device IDK071385
510k NumberK071385
Device Name:STERRAD 100NX STERILIZER
ClassificationSterilizer, Chemical
Applicant ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine,  CA  92718
ContactReuben Lawson
CorrespondentReuben Lawson
ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine,  CA  92718
Product CodeMLR  
CFR Regulation Number880.6860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-18
Decision Date2007-11-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20705037014900 K071385 000
10705037047598 K071385 000
10705037047581 K071385 000
10705037014507 K071385 000
10705037014491 K071385 000

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