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 |