510(k) K973654
K973654 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "VIAL-MATE RECONSTITUTION DEVICE (2B8071)". The FDA issued a decision of Substantially Equivalent on Oct 24, 1997. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 24, 1997
- Date Received
- Sep 25, 1997
- 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
- 510(k)