The following data is part of a premarket notification filed by Chemence Medical, Inc. with the FDA for Exofin Precision Pen.
| Device ID | K212246 |
| 510k Number | K212246 |
| Device Name: | Exofin Precision Pen |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | Chemence Medical, Inc. 200 Technology Drive Alpharetta, GA 30115 |
| Contact | Charnelle Thomas |
| Correspondent | Charnelle Thomas Chemence Medical, Inc. 200 Technology Drive Alpharetta, GA 30115 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-19 |
| Decision Date | 2021-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811220033538 | K212246 | 000 |
| 10854137001655 | K212246 | 000 |
| 00854137001641 | K212246 | 000 |