S Dispensing Line

Syringe, Piston

AEA Srl

The following data is part of a premarket notification filed by Aea Srl with the FDA for S Dispensing Line.

Pre-market Notification Details

Device IDK192770
510k NumberK192770
Device Name:S Dispensing Line
ClassificationSyringe, Piston
Applicant AEA Srl via Fiume 16 Angeli Di Rosora,  IT 60030
ContactMichele Mengoni
CorrespondentMichele Mengoni
AEA Srl via Fiume 16 Angeli Di Rosora,  IT 60030
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-12-17

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