The following data is part of a premarket notification filed by Ribbond, Inc. with the FDA for Ribbond - Triaxial.
| Device ID | K013881 |
| 510k Number | K013881 |
| Device Name: | RIBBOND - TRIAXIAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | RIBBOND, INC. 1402 3RD AVE., SUITE 1030 Seattle, WA 98101 -2118 |
| Contact | Shoshana Rudo Driver |
| Correspondent | Shoshana Rudo Driver RIBBOND, INC. 1402 3RD AVE., SUITE 1030 Seattle, WA 98101 -2118 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2002-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D758X0 | K013881 | 000 |