The following data is part of a premarket notification filed by Chemence Medical Inc with the FDA for Derma+flex Qs High Viscosity Tissue Adhesive.
| Device ID | K162352 |
| 510k Number | K162352 |
| Device Name: | Derma+flex QS High Viscosity Tissue Adhesive |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| 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 | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-23 |
| Decision Date | 2016-12-22 |