The following data is part of a premarket notification filed by Angeline Group Ltd. with the FDA for Surgical Face Mask; Surgical Face Mask.
| Device ID | K110027 |
| 510k Number | K110027 |
| Device Name: | SURGICAL FACE MASK; SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | ANGELINE GROUP LTD. NO.45, MINSHENG RD DANSHUI TOWN Taipei County, TW 251 |
| Contact | Michael Lee |
| Correspondent | Michael Lee ANGELINE GROUP LTD. NO.45, MINSHENG RD DANSHUI TOWN Taipei County, TW 251 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-05 |
| Decision Date | 2011-08-05 |
| Summary: | summary |