The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Dressing Change Tray.
| Device ID | K952334 |
| 510k Number | K952334 |
| Device Name: | DRESSING CHANGE TRAY |
| Classification | Wound Dressing Kit |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. Hauppauge, NY 11788 |
| Contact | Eileen Rama |
| Correspondent | Eileen Rama BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. Hauppauge, NY 11788 |
| Product Code | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-18 |
| Decision Date | 1995-07-14 |