The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Busse Isolation And Procedural Masks.
| Device ID | K940720 |
| 510k Number | K940720 |
| Device Name: | BUSSE ISOLATION AND PROCEDURAL MASKS |
| Classification | Mask, Surgical |
| 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 | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-18 |
| Decision Date | 1994-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817643020537 | K940720 | 000 |
| 00817643020148 | K940720 | 000 |
| 00849233000957 | K940720 | 000 |
| 20849233000937 | K940720 | 000 |
| 00849233000926 | K940720 | 000 |
| 10817643020534 | K940720 | 000 |
| 10817643020145 | K940720 | 000 |