Submission Details
| 510(k) Number | K112791 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
SITESCRUB IPA DEVICE
Feb 2012
Decision
151d
Days
—
Risk
About This 510(k) Submission
K112791 is an FDA 510(k) clearance for the SITESCRUB IPA DEVICE, 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 review panel.
Device Classification
| Product Code | LKB — Pad, Alcohol, Device Disinfectant |
| Device Class | — |
Manufacturer
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