The following data is part of a premarket notification filed by Denali Corporation with the FDA for Triumph Resin Dam.
| Device ID | K151945 |
| 510k Number | K151945 |
| Device Name: | Triumph Resin Dam |
| Classification | Dam, Rubber |
| 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 | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-14 |
| Decision Date | 2016-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8374750000 | K151945 | 000 |
| D8374710000 | K151945 | 000 |