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 |