The following data is part of a premarket notification filed by Oral-b Laboratories with the FDA for Fibretwins.
| Device ID | K913603 |
| 510k Number | K913603 |
| Device Name: | FIBRETWINS |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ORAL-B LABORATORIES ONE LAGOON DR. Redwood City, CA 94065 |
| Contact | Sharon Snyder |
| Correspondent | Sharon Snyder ORAL-B LABORATORIES ONE LAGOON DR. Redwood City, CA 94065 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-14 |
| Decision Date | 1991-09-30 |