510(k) K962581
K962581 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STOPCOCK MANIFOLD GANGS". The FDA issued a decision of Substantially Equivalent on Aug 28, 1996. The device falls under product code FMG (Stopcock, I.V. Set), 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
- Aug 28, 1996
- Date Received
- Jul 1, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stopcock, I.V. Set
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)