The following data is part of a premarket notification filed by Valumax Intl., Inc. with the FDA for Valumax Surgical Masks (blue, Pink, Green, Yellow, White And Peach) With Or Without Visors, Ties And Earloops.
| Device ID | K040333 |
| 510k Number | K040333 |
| Device Name: | VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS |
| Classification | Mask, Surgical |
| Applicant | VALUMAX INTL., INC. 848 HAUSMAN RD. Allentown, PA 18104 |
| Contact | Janet Jia |
| Correspondent | Janet Jia VALUMAX INTL., INC. 848 HAUSMAN RD. Allentown, PA 18104 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-11 |
| Decision Date | 2004-06-07 |
| Summary: | summary |