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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K180650
Device Name Amsel Endo Occluder
Applicant
Amsel Medical Corporation
171 Hamilton Street
Cambridge,  MA  02139
Applicant Contact Yoram Levy
Correspondent
Amsel Medical Corporation
171 Hamilton Street
Cambridge,  MA  02139
Correspondent Contact Leo L Basta
Regulation Number878.4300
Classification Product Code
FZP  
Date Received03/13/2018
Decision Date 11/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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