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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K162916
Device Name 3NT endoscopy system
Applicant
3nt Medical , Ltd.
22 Hamelacha St. P.O. Box 11384
Rosh Ha'Ayin,  IL 4809169
Applicant Contact Ehud Bendory
Correspondent
Orly Maor
25 Sirkin St.
Kfar Saba,  IL 44421
Correspondent Contact Orly Maor
Regulation Number874.4760
Classification Product Code
EOB  
Date Received10/17/2016
Decision Date 02/24/2017
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
Predetermined Change
Control Plan Authorized		 No
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