The following data is part of a premarket notification filed by Mars White Knight with the FDA for Precept Micro-gard Laser Mask.
| Device ID | K891409 |
| 510k Number | K891409 |
| Device Name: | PRECEPT MICRO-GARD LASER MASK |
| Classification | Mask, Surgical |
| Applicant | MARS WHITE KNIGHT P.O. BOX 6874 Asheville, NC 28816 |
| Contact | Walt Kogut |
| Correspondent | Walt Kogut MARS WHITE KNIGHT P.O. BOX 6874 Asheville, NC 28816 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-14 |
| Decision Date | 1989-04-07 |