510(k) K140155
K140155 is an FDA 510(k) premarket notification submitted by Cardinal Health200, LLC for the device "SECURE-GARD SURGICAL AND PROCEDURE FACE MASK". The FDA issued a decision of Substantially Equivalent on June 20, 2014. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Cardinal Health200, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2014
- Date Received
- January 22, 2014
- 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