510(k) K010623
K010623 is an FDA 510(k) premarket notification submitted by Bioject, Inc. for the device "RECONSTITUTION KIT & VIAL CONNECTOR". The FDA issued a decision of Substantially Equivalent on April 5, 2001. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Bioject, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2001
- Date Received
- March 2, 2001
- 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