The following data is part of a premarket notification filed by Surgilite Intl., Inc. with the FDA for Multiple Surgical Mask.
| Device ID | K822481 |
| 510k Number | K822481 |
| Device Name: | MULTIPLE SURGICAL MASK |
| Classification | Mask, Surgical |
| Applicant | SURGILITE INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-17 |
| Decision Date | 1982-09-17 |