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 | K171442 |
| 510k Number | K171442 |
| 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 Broadley |
| Correspondent | Kenneth Broadley Chemence Medical, Inc. 200 Technology Drive Alpharetta, GA 30005 |
| Product Code | OMD |
| CFR Regulation Number | 878.4011 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-16 |
| Decision Date | 2017-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854137001235 | K171442 | 000 |
| 00854137001511 | K171442 | 000 |
| 00854137001498 | K171442 | 000 |
| 00854137001610 | K171442 | 000 |
| 10854137001808 | K171442 | 000 |
| 10854137001754 | K171442 | 000 |