The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Suprapubic Flow Controller.
| Device ID | K904798 |
| 510k Number | K904798 |
| Device Name: | SUPRAPUBIC FLOW CONTROLLER |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Daniel Dillon |
| Correspondent | Daniel Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-24 |
| Decision Date | 1991-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761002974 | K904798 | 000 |
| 04042761002967 | K904798 | 000 |
| 04042761002950 | K904798 | 000 |
| 04042761002943 | K904798 | 000 |
| 04042761002998 | K904798 | 000 |