The following data is part of a premarket notification filed by Norwich Eaton Pharmaceuticals, Inc. with the FDA for Vivonex Tungsten Tip Tube Placement.
Device ID | K821231 |
510k Number | K821231 |
Device Name: | VIVONEX TUNGSTEN TIP TUBE PLACEMENT |
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 | 1982-04-27 |
Decision Date | 1982-05-10 |