The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Surgical Face Mask.
| Device ID | K830890 |
| 510k Number | K830890 |
| Device Name: | SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-21 |
| Decision Date | 1983-04-27 |