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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 K220004
Device Name Zsquare ENT-Flex Endoscope
Applicant
Zsquare, Ltd
43 Hasivim Street
Petah Tikva,  IL 4959501
Applicant Contact Asaf Shahmoon
Correspondent
Zsquare, Ltd
43 Hasivim Street
Petah Tikva,  IL 4959501
Correspondent Contact Liat Diamant-Porat
Regulation Number874.4760
Classification Product Code
EOB  
Date Received01/04/2022
Decision Date 06/14/2022
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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