FDA 510(k) K191461, Cutaneous Tissue Adhesive With Mesh

Device Classification Name: Cutaneous Tissue Adhesive With Mesh
510(k) Number: K191461
Device Name: Exofin Fusion Skin Closure System
Applicant: Chemence Medical, Inc.
Regulation Number: 878.4011
Classification Product Code: OMD
Date Received: 06/03/2019
Decision Date: 06/05/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

Total Pages: 966
Fully Redacted Pages: 905
Content Pages: 61