The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Olbert Catheter Sys For Ureteral Dilation.
| Device ID | K851463 |
| 510k Number | K851463 |
| Device Name: | OLBERT CATHETER SYS FOR URETERAL DILATION |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | James Hartigan |
| Correspondent | James Hartigan MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-05-23 |