510(k) K984060
K984060 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "LUER ACCESS INJECTION SITE". The FDA issued a decision of Substantially Equivalent on Jul 26, 1999. The device falls under product code FPA (Set, Administration, Intravascular), 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
- Jul 26, 1999
- Date Received
- Nov 13, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)