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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 K230966
Device Name angiOCCLUDE Ligating Clips
Applicant
A2 Medical Systems, LLC
6387 Technology Ave.
Kalamazoo,  MI  49009
Applicant Contact Robert Hall
Correspondent
A2 Medical Systems, LLC
6387 Technology Ave.
Kalamazoo,  MI  49009
Correspondent Contact Robert Hall
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
DSS  
Date Received04/05/2023
Decision Date 09/19/2023
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
Predetermined Change
Control Plan Authorized		 No
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