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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cutaneous Tissue Adhesive With Mesh
510(k) Number K191461
Device Name Exofin Fusion Skin Closure System
Applicant
Chemence Medical, Inc.
200 Technology Dr.
Alpharetta,  GA  30005
Applicant Contact Kenneth N Broadley
Correspondent
Chemence Medical, Inc.
200 Technology Dr.
Alpharetta,  GA  30005
Correspondent Contact Kenneth N Broadley
Regulation Number878.4011
Classification Product Code
OMD  
Date Received06/03/2019
Decision Date 06/05/2020
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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