510(k) K221173
K221173 is an FDA 510(k) premarket notification submitted by Jiangxi Sanhao Medical Instruments Co.,Ltd for the device "Surgical Mask (Model: 0868F, 0866F)". The FDA issued a decision of Substantially Equivalent on Jul 6, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Jiangxi Sanhao Medical Instruments Co.,Ltd has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 6, 2022
- Date Received
- Apr 25, 2022
- 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
- 510(k)