The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for No Profile Olbert Catheter System For Urology.
| Device ID | K905181 |
| 510k Number | K905181 |
| Device Name: | NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Nancy Koffman |
| Correspondent | Nancy Koffman 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 | 1990-11-19 |
| Decision Date | 1991-03-06 |