The following data is part of a premarket notification filed by Busse Hospital Disposables with the FDA for Busse Extension Set.
| Device ID | K141285 |
| 510k Number | K141285 |
| Device Name: | BUSSE EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BUSSE HOSPITAL DISPOSABLES 75 ARKAY DRIVE Hauppauge, NY 11788 -3707 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSPITAL DISPOSABLES 75 ARKAY DRIVE Hauppauge, NY 11788 -3707 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-16 |
| Decision Date | 2015-02-19 |
| Summary: | summary |