K112791 is an FDA 510(k) clearance for the SITESCRUB IPA DEVICE. This device is classified as a Pad, Alcohol, Device Disinfectant.
Submitted by C. R. Bard (Salt Lake Ciy,, US). The FDA issued a Cleared decision on February 24, 2012, 151 days after receiving the submission on September 26, 2011.
This device falls under the General Hospital FDA review panel.
| 510(k) Number | K112791 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2011 |
| Decision Date | February 24, 2012 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LKB - Pad, Alcohol, Device Disinfectant |
| Device Class | - |