The following data is part of a premarket notification filed by Norwich Eaton Pharmaceuticals, Inc. with the FDA for Vivonex Tungsten Tip Tube-twisted Wire.
| Device ID | K831971 |
| 510k Number | K831971 |
| Device Name: | VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | NORWICH EATON PHARMACEUTICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-20 |
| Decision Date | 1983-09-01 |