The following data is part of a premarket notification filed by Busse Hospital Disposables with the FDA for Busse Hospital Disposables Urethral Catheter.
| Device ID | K041464 |
| 510k Number | K041464 |
| Device Name: | BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER |
| Classification | Catheter, Straight |
| Applicant | BUSSE HOSPITAL DISPOSABLES PO BOX 11067 Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSPITAL DISPOSABLES PO BOX 11067 Hauppauge, NY 11788 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-02 |
| Decision Date | 2004-11-05 |
| Summary: | summary |