510(k) K201517
K201517 is an FDA 510(k) premarket notification submitted by Aok Tooling Limited for the device "Plain Surgical Mask". The FDA issued a decision of Substantially Equivalent on Sep 4, 2020. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Aok Tooling Limited has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 4, 2020
- Date Received
- Jun 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
- 510(k)