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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 K202727
Device Name Peregrine Endoscopy System
3NT Medical Ltd.
22 HaMelacha St., POB 11384
Rosh Ha'Ayin,  IL 4809169
Applicant Contact Ehud Bendory
Orly Maor
25A Sirkin Street
Kfar Saba,  IL 4442156
Correspondent Contact Orly Maor
Regulation Number874.4760
Classification Product Code
Date Received09/17/2020
Decision Date 07/23/2021
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