The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Dermabond Advanced Topical Skin Adhesive, High Viscosity Dermabond Mini Topical Skin Adhesive.
| Device ID | K152096 |
| 510k Number | K152096 |
| Device Name: | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 -0151 |
| Contact | Donna Marshall |
| Correspondent | Donna Marshall Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 -0151 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-28 |
| Decision Date | 2015-10-22 |
| Summary: | summary |