510(k) K211750
K211750 is an FDA 510(k) premarket notification submitted by National Bridge Industrial (S.Z.) Co., Ltd. for the device "Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)". The FDA issued a decision of Substantially Equivalent on Dec 20, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2021
- Date Received
- Jun 7, 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
- 510(k)