The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Olbert Catheter System For Biliary Tract Dilatatio.
| Device ID | K851647 |
| 510k Number | K851647 |
| Device Name: | OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Scott J Mindredo |
| Correspondent | Scott J Mindredo MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-22 |
| Decision Date | 1985-07-03 |