510(k) K210524
K210524 is an FDA 510(k) premarket notification submitted by Changzhou Holymed Products Co., Ltd. for the device "Surgical Mask". The FDA issued a decision of Substantially Equivalent on July 7, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Changzhou Holymed Products Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2021
- Date Received
- February 23, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type