The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Dermabond Nx Adhesive Model: Dnx6, Dnx12.
| Device ID | K100423 |
| 510k Number | K100423 |
| Device Name: | DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | ETHICON, INC. PO BOX 151, ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Contact | Neelu Medhekar |
| Correspondent | Neelu Medhekar ETHICON, INC. PO BOX 151, ROUTE 22 WEST 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 | 2010-02-16 |
| Decision Date | 2010-05-04 |
| Summary: | summary |