The following data is part of a premarket notification filed by White Knight Healthcare with the FDA for White Knight Surgeon's Vest.
| Device ID | K951984 |
| 510k Number | K951984 |
| Device Name: | WHITE KNIGHT SURGEON'S VEST |
| Classification | Gown, Surgical |
| Applicant | WHITE KNIGHT HEALTHCARE P.O. BOX 6874 Asheville, NC 28816 |
| Contact | Frank R Dastoli |
| Correspondent | Frank R Dastoli WHITE KNIGHT HEALTHCARE P.O. BOX 6874 Asheville, NC 28816 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-27 |
| Decision Date | 1995-07-25 |