510(k) K932477
K932477 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET". The FDA issued a decision of Substantially Equivalent on Jun 10, 1994. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 10, 1994
- Date Received
- May 24, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type
- 510(k)