ABS BLOWER, ABS NOZZLE, MODEL 1001

Air Filter Portable Apparatus

NIMBIC SYSTEMS, LLC

The following data is part of a premarket notification filed by Nimbic Systems, Llc with the FDA for Abs Blower, Abs Nozzle, Model 1001.

Pre-market Notification Details

Device IDK092801
510k NumberK092801
Device Name:ABS BLOWER, ABS NOZZLE, MODEL 1001
ClassificationAir Filter Portable Apparatus
Applicant NIMBIC SYSTEMS, LLC 4910 WRIGHT ROAD, SUITE 170 Stafford,  TX  77477
ContactSean Self
CorrespondentSean Self
NIMBIC SYSTEMS, LLC 4910 WRIGHT ROAD, SUITE 170 Stafford,  TX  77477
Product CodeORC  
CFR Regulation Number878.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-11
Decision Date2011-05-20
Summary:summary

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