510(k) K131879
K131879 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "KC 300 SURGICAL MASK". The FDA issued a decision of Substantially Equivalent on December 20, 2013. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2013
- Date Received
- June 24, 2013
- 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