510(k) K954970
K954970 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "STOPCOCK & LUER LOCK PLUG". The FDA issued a decision of Substantially Equivalent on April 22, 1996. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Medex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1996
- Date Received
- October 30, 1995
- 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