The following data is part of a premarket notification filed by Top Wholesome Enterprise Co., Ltd. with the FDA for Top Wholesome Face Mask.
| Device ID | K984389 |
| 510k Number | K984389 |
| Device Name: | TOP WHOLESOME FACE MASK |
| Classification | Mask, Surgical |
| Applicant | TOP WHOLESOME ENTERPRISE CO., LTD. A.P. NAKARINTR TOWER 18TH FL 333 MOO 9, SRINAKARINTR RD. Bangna, TH 10260 |
| Contact | Urai Charoensuk |
| Correspondent | Urai Charoensuk TOP WHOLESOME ENTERPRISE CO., LTD. A.P. NAKARINTR TOWER 18TH FL 333 MOO 9, SRINAKARINTR RD. Bangna, TH 10260 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-08 |
| Decision Date | 1999-04-09 |