The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Panda(r) Needle Catheter Jejunostomy Tube.
| Device ID | K891109 |
| 510k Number | K891109 |
| Device Name: | PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
| Contact | Martha C Miller |
| Correspondent | Martha C Miller CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-02 |
| Decision Date | 1989-05-08 |