The following data is part of a premarket notification filed by Chemence Medical, Inc. with the FDA for Exofin High Viscosity Topical Skin Adhesive.
| Device ID | K200264 |
| 510k Number | K200264 |
| Device Name: | Exofin High Viscosity Topical Skin Adhesive |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | Chemence Medical, Inc. 200 Technology Drive Alpharetta, GA 30005 |
| Contact | Charnelle Thomas |
| Correspondent | Charnelle Thomas Chemence Medical, Inc. 200 Technology Drive Alpharetta, GA 30005 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2020-12-17 |