510(k) K201537
K201537 is an FDA 510(k) premarket notification submitted by Shandong Shengquan New Material Co., Ltd. for the device "Protective Face Mask for Medical Use". The FDA issued a decision of Substantially Equivalent on September 4, 2020. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Shandong Shengquan New Material Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2020
- Date Received
- June 8, 2020
- 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