KC 300 SURGICAL MASK
FDA 510(k) clearance K131879 · decided 2013-12-20
Clearance details
- K-number
- K131879
- Device name
- KC 300 SURGICAL MASK
- Applicant
- Kimberly-Clark Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-24
- Decision date
- 2013-12-20
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, Wr recall (Z-1059-2023) | Owens & Minor Distribution, Inc. | 2023-02-03 |