The following data is part of a premarket notification filed by Ribbond, Inc. with the FDA for Ribbond(tm).
| Device ID | K913040 |
| 510k Number | K913040 |
| Device Name: | RIBBOND(TM) |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | RIBBOND, INC. 1003 COBB MEDICAL CENTER Seattle, WA 98191 |
| Contact | David N Rudo |
| Correspondent | David N Rudo RIBBOND, INC. 1003 COBB MEDICAL CENTER Seattle, WA 98191 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-09 |
| Decision Date | 1991-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D758U0 | K913040 | 000 |
| D758T0 | K913040 | 000 |
| D758O0 | K913040 | 000 |