The following data is part of a premarket notification filed by A Plus International, Inc with the FDA for Solution Face Masks.
| Device ID | K031353 |
| 510k Number | K031353 |
| Device Name: | SOLUTION FACE MASKS |
| Classification | Mask, Surgical |
| Applicant | A PLUS INTERNATIONAL, INC 5138 EUCALYPTUS AVE. Chino, CA 91710 |
| Contact | Solomon Chen |
| Correspondent | Alfredo J Quattrone CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 942732 (MS-357) Sacramento, CA 94234 -7320 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-04-29 |
| Decision Date | 2003-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10326053117616 | K031353 | 000 |
| 10326053119108 | K031353 | 000 |
| 10326053118705 | K031353 | 000 |