The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Buse Staff Protection Gowns And Kits.
| Device ID | K941845 |
| 510k Number | K941845 |
| Device Name: | BUSE STAFF PROTECTION GOWNS AND KITS |
| Classification | Gown, Isolation, Surgical |
| 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 | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-14 |
| Decision Date | 1995-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817643022265 | K941845 | 000 |
| 00849233016668 | K941845 | 000 |
| 00849233000575 | K941845 | 000 |