The following data is part of a premarket notification filed by White Knight Healthcare with the FDA for Monogard Face Shield.
| Device ID | K943809 |
| 510k Number | K943809 |
| Device Name: | MONOGARD FACE SHIELD |
| Classification | Accessory, Surgical Apparel |
| Applicant | WHITE KNIGHT HEALTHCARE 175 DEAVEAVIEW RD. P.O.BOX 6874 Ashville, NC 28806 |
| Contact | Frank R Dastoli |
| Correspondent | Frank R Dastoli WHITE KNIGHT HEALTHCARE 175 DEAVEAVIEW RD. P.O.BOX 6874 Ashville, NC 28806 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-04 |
| Decision Date | 1994-11-28 |