The following data is part of a premarket notification filed by Chemence Medical Products Inc. with the FDA for Exofin High Viscosity Tissue Adhesive.
| Device ID | K152476 |
| 510k Number | K152476 |
| Device Name: | Exofin High Viscosity Tissue Adhesive |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | CHEMENCE MEDICAL PRODUCTS INC. 200 Technology Drive Alpharetta, GA 30005 |
| Contact | Kenneth Broadley |
| Correspondent | Kenneth Broadley CHEMENCE MEDICAL PRODUCTS INC. 200 Technology Drive Alpharetta, GA 30005 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2016-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818566019865 | K152476 | 000 |
| 10818566019858 | K152476 | 000 |
| 00854137001153 | K152476 | 000 |
| 00854137001146 | K152476 | 000 |
| 00854137001481 | K152476 | 000 |
| 20854137001621 | K152476 | 000 |
| 10854137001679 | K152476 | 000 |
| 30854137001147 | K152476 | 000 |