510(k) K201095
K201095 is an FDA 510(k) premarket notification submitted by Homtex, Inc. for the device "Sovereign America Surgical Face Mask". The FDA issued a decision of Substantially Equivalent on Mar 19, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Homtex, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 19, 2021
- Date Received
- Apr 24, 2020
- Clearance Type
- Abbreviated
- 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)