The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Noprofile Olbert Catheter System.
| Device ID | K945061 |
| 510k Number | K945061 |
| Device Name: | NOPROFILE OLBERT CATHETER SYSTEM |
| Classification | Catheter, Urological |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Stephen B Anderson |
| Correspondent | Stephen B Anderson MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | KOD |
| Subsequent Product Code | EZN |
| Subsequent Product Code | FGE |
| Subsequent Product Code | KOE |
| Subsequent Product Code | LJE |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-14 |
| Decision Date | 1995-03-09 |