Submission Details
| 510(k) Number | K101309 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
EXELINT ALUMINUM HUB BLUNT NEEDLES
Oct 2010
Decision
163d
Days
Class 2
Risk
About This 510(k) Submission
K101309 is an FDA 510(k) clearance for the EXELINT ALUMINUM HUB BLUNT NEEDLES, 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 review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
Manufacturer
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