The following data is part of a premarket notification filed by Onyx Medical Corp. with the FDA for Face-it Shield.
| Device ID | K942022 |
| 510k Number | K942022 |
| Device Name: | FACE-IT SHIELD |
| Classification | Accessory, Surgical Apparel |
| Applicant | ONYX MEDICAL CORP. 445 COLOMA Sausalito, CA 94965 |
| Contact | Roger Machson |
| Correspondent | Roger Machson ONYX MEDICAL CORP. 445 COLOMA Sausalito, CA 94965 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-26 |
| Decision Date | 1994-07-08 |