K101309 is an FDA 510(k) clearance for the EXELINT ALUMINUM HUB BLUNT NEEDLES. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Exelint International, Co. (Los Angeles, US). The FDA issued a Cleared decision on October 20, 2010, 163 days after receiving the submission on May 10, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K101309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2010 |
| Decision Date | October 20, 2010 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |