510(k) K173062
K173062 is an FDA 510(k) premarket notification submitted by V&Q Manufacturing Corporation for the device "Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))". The FDA issued a decision of Substantially Equivalent on Jan 25, 2018. 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
- Jan 25, 2018
- Date Received
- Sep 28, 2017
- 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)