The following data is part of a premarket notification filed by Knight Medical, Inc. with the FDA for Panda Needle Catheter Jejunostomy Kit.
| Device ID | K921127 |
| 510k Number | K921127 |
| Device Name: | PANDA NEEDLE CATHETER JEJUNOSTOMY KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | KNIGHT MEDICAL, INC. 320 CHARLES ST. Cambridge, MA 02141 |
| Contact | David Kreider |
| Correspondent | David Kreider KNIGHT MEDICAL, INC. 320 CHARLES ST. Cambridge, MA 02141 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-10 |
| Decision Date | 1993-01-04 |