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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 K172479
Device Name Amsel Occluder Device
Applicant
Amsel Medical
171 Hamilton St.
Cambridge,  MA  02139
Applicant Contact Raanan Miller
Correspondent
Northstar Biomedical Associates
93 Benefit St.
Providence,  RI  02904
Correspondent Contact Leo Basta
Regulation Number878.4300
Classification Product Code
FZP  
Date Received08/16/2017
Decision Date 09/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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