MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
FDA 510(k) clearance K091357 · decided 2009-08-10
Clearance details
- K-number
- K091357
- Device name
- MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
- Applicant
- Kimberly-Clark Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-08
- Decision date
- 2009-08-10
- Days to decision
- 94 days
- Clearance type
- Abbreviated
- Product code
- FYA
- 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 |
|---|---|---|
| MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Hondu recall (Z-2017-2012) | Kimberly-Clark Corporation | 2012-07-16 |
| MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made i recall (Z-2018-2012) | Kimberly-Clark Corporation | 2012-07-16 |