The following data is part of a premarket notification filed by White Knight Healthcare, Inc. with the FDA for White Knight Masks, Blue, Pink, Yellow, White Masks (13 Models).
| Device ID | K001893 |
| 510k Number | K001893 |
| Device Name: | WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) |
| Classification | Mask, Surgical |
| Applicant | WHITE KNIGHT HEALTHCARE, INC. 3234 ELLA LN. New Port Richey, FL 34655 |
| Contact | Art Ward |
| Correspondent | Art Ward WHITE KNIGHT HEALTHCARE, INC. 3234 ELLA LN. New Port Richey, FL 34655 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-21 |
| Decision Date | 2001-04-02 |