The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Dressing Change Trays.
| Device ID | K963260 |
| 510k Number | K963260 |
| Device Name: | DRESSING CHANGE TRAYS |
| Classification | Syringe, Piston |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Contact | Eileen Rama |
| Correspondent | Eileen Rama BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-20 |
| Decision Date | 1996-11-22 |