510(k) K101309
K101309 is an FDA 510(k) premarket notification submitted by Exelint International, Co. for the device "EXELINT ALUMINUM HUB BLUNT NEEDLES". The FDA issued a decision of Substantially Equivalent on Oct 20, 2010. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Exelint International, Co. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 20, 2010
- Date Received
- May 10, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type