The following data is part of a premarket notification filed by Neodyne Biosciences, Inc. with the FDA for Neodyne Dressing.
| Device ID | K112131 |
| 510k Number | K112131 |
| Device Name: | NEODYNE DRESSING |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | NEODYNE BIOSCIENCES, INC. 127 Independence Drive Menlo Park, CA 94025 |
| Contact | Peggy Mclaughlin |
| Correspondent | Peggy Mclaughlin NEODYNE BIOSCIENCES, INC. 127 Independence Drive Menlo Park, CA 94025 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-26 |
| Decision Date | 2011-09-29 |
| Summary: | summary |