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FDA 510(k), K171442, Exofin Fusion Skin Closure System
FDA 510(k), K171442, Exofin Fusion Skin Closure System
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510(K) Number: K171442
Device Name: Exofin Fusion Skin Closure System
Manufacturer: Chemence Medical, Inc.
Device Classification Name: Cutaneous Tissue Adhesive With Mesh
Regulation Number: 878.4011
Classification Product Code: OMD
Date Received: 05/16/2017
Decision Date: 09/25/2017
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Exofin Fusion Skin Closure System
Manufacturer: Chemence Medical, Inc.
Device Classification Name: Cutaneous Tissue Adhesive With Mesh
Regulation Number: 878.4011
Classification Product Code: OMD
Date Received: 05/16/2017
Decision Date: 09/25/2017
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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