The following data is part of a premarket notification filed by Ray Co., Ltd. with the FDA for Ear-friendly Mask.
| Device ID | K211105 |
| 510k Number | K211105 |
| Device Name: | Ear-Friendly Mask |
| Classification | Mask, Surgical |
| Applicant | Ray Co., Ltd. 38, Simin-daero, Manan-gu Anyang-si, KR 14098 |
| Contact | Changhwan Lee |
| Correspondent | Rafael Aguila Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, FL 33155 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-04-13 |
| Decision Date | 2021-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800003025005 | K211105 | 000 |
| 08800003025008 | K211105 | 000 |