510(k) K963012
K963012 is an FDA 510(k) premarket notification submitted by Bioject, Inc. for the device "BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)". The FDA issued a decision of Substantially Equivalent on October 15, 1996. 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
- October 15, 1996
- Date Received
- August 2, 1996
- 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