510(k) K041779
K041779 is an FDA 510(k) premarket notification submitted by Nipro Medical Corp. for the device "NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L". The FDA issued a decision of Substantially Equivalent on September 21, 2004. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Nipro Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2004
- Date Received
- July 1, 2004
- 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