The following data is part of a premarket notification filed by Shuenn Bao Shing Corp. with the FDA for Earloop Face Mask.
| Device ID | K990719 |
| 510k Number | K990719 |
| Device Name: | EARLOOP FACE MASK |
| Classification | Mask, Surgical |
| Applicant | SHUENN BAO SHING CORP. 11TH FL., 35, MIN CHUAN W. RD Taipei, TW |
| Contact | Charlie Chen |
| Correspondent | Charlie Chen SHUENN BAO SHING CORP. 11TH FL., 35, MIN CHUAN W. RD Taipei, TW |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-05 |
| Decision Date | 1999-07-12 |