The following data is part of a premarket notification filed by Johnson & Johnson Interventional Systems with the FDA for Palmaz Biliary Stent.
| Device ID | K905720 |
| 510k Number | K905720 |
| Device Name: | PALMAZ BILIARY STENT |
| Classification | Catheter, Percutaneous |
| Applicant | JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS 35 TECHNOLOGY DR. P.O. BOX 4917 Warren, NJ 07060 |
| Contact | Raymond E Ursick |
| Correspondent | Raymond E Ursick JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS 35 TECHNOLOGY DR. P.O. BOX 4917 Warren, NJ 07060 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-21 |
| Decision Date | 1991-02-05 |