Sinusway Dilation System

Instrument, Ent Manual Surgical

3NT Medical Ltd.

The following data is part of a premarket notification filed by 3nt Medical Ltd. with the FDA for Sinusway Dilation System.

Pre-market Notification Details

Device IDK181838
510k NumberK181838
Device Name:Sinusway Dilation System
ClassificationInstrument, Ent Manual Surgical
Applicant 3NT Medical Ltd. 22 Hamelacha Street PO Box 11384 Rosh Ha'ayin,  IL 4809169
ContactEhud Bendory
CorrespondentOrly Maor
Orly Maor 25 Sirkin Street Kfar Saba,  IL 44421
Product CodeLRC  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-10
Decision Date2018-12-20
Summary:summary

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