The following data is part of a premarket notification filed by Chemence Medical, Inc. with the FDA for Exofin Fusion Skin Closure System.
Device ID | K191461 |
510k Number | K191461 |
Device Name: | Exofin Fusion Skin Closure System |
Classification | Cutaneous Tissue Adhesive With Mesh |
Applicant | Chemence Medical, Inc. 200 Technology Drive Alpharetta, GA 30005 |
Contact | Kenneth N Broadley |
Correspondent | Kenneth N Broadley Chemence Medical, Inc. 200 Technology Drive Alpharetta, GA 30005 |
Product Code | OMD |
CFR Regulation Number | 878.4011 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-03 |
Decision Date | 2020-06-05 |