510(k) K061143
K061143 is an FDA 510(k) premarket notification submitted by Halkey-Roberts Corp. for the device "ROBERTSITE STOPCOCK". The FDA issued a decision of Substantially Equivalent on May 10, 2006. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Halkey-Roberts Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2006
- Date Received
- April 25, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stopcock, I.V. Set
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type