510(k) K212097
K212097 is an FDA 510(k) premarket notification submitted by Hebei Titans Hongsen Medical Technology Co., Ltd. for the device "Disposable medical surgical mask". The FDA issued a decision of Substantially Equivalent on August 18, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Hebei Titans Hongsen Medical Technology Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2021
- Date Received
- July 6, 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