The following data is part of a premarket notification filed by A Plus International, Inc. with the FDA for Procedure Mask, Surgical Mask.
| Device ID | K213001 |
| 510k Number | K213001 |
| Device Name: | Procedure Mask, Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | A Plus International, Inc. 5138 Eucalyptus Ave. Chino, CA 91710 |
| Contact | Solomon Chen |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00683534090268 | K213001 | 000 |
| 00683534090220 | K213001 | 000 |
| 00683534090206 | K213001 | 000 |
| 00683534090244 | K213001 | 000 |