The following data is part of a premarket notification filed by Denali Corporation with the FDA for Resolve 2.0.
| Device ID | K152322 |
| 510k Number | K152322 |
| Device Name: | Resolve 2.0 |
| Classification | External Cleaning Solution |
| Applicant | DENALI CORPORATION 134 OLD WASHINGTON STREET Hanover, MA 02339 |
| Contact | Jan G Stannard |
| Correspondent | Jan G Stannard DENALI CORPORATION 134 OLD WASHINGTON STREET Hanover, MA 02339 |
| Product Code | PME |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-17 |
| Decision Date | 2015-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8374850000 | K152322 | 000 |
| D8374810050 | K152322 | 000 |
| D8374810000 | K152322 | 000 |