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 |