Submission Details
| 510(k) Number | K130404 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 2013 |
| Decision Date | July 05, 2013 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
TIBURON SURGICAL DRAPE
Jul 2013
Decision
136d
Days
Class 2
Risk
About This 510(k) Submission
K130404 is an FDA 510(k) clearance for the TIBURON SURGICAL DRAPE, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on July 5, 2013, 136 days after receiving the submission on February 19, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.
Device Classification
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4370 |
Manufacturer
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