510(k) K240258
K240258 is an FDA 510(k) premarket notification submitted by Makrite Industries, Inc. for the device "Disposable Medical Face Mask (M643BE)". The FDA issued a decision of Substantially Equivalent on April 18, 2024. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Makrite Industries, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2024
- Date Received
- January 31, 2024
- 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