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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, ent manual surgical
510(k) Number K181838
Device Name Sinusway Dilation System
3NT Medical Ltd.
22 Hamelacha Street PO Box 11384
Rosh Ha'ayin,  IL 4809169
Applicant Contact Ehud Bendory
Orly Maor
25 Sirkin Street
Kfar Saba,  IL 44421
Correspondent Contact Orly Maor
Regulation Number874.4420
Classification Product Code
Date Received07/10/2018
Decision Date 12/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No