510(k) K211105
K211105 is an FDA 510(k) premarket notification submitted by Ray Co., Ltd. for the device "Ear-Friendly Mask". The FDA issued a decision of Substantially Equivalent on May 17, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Ray Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2021
- Date Received
- April 13, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type