510(k) K810375
K810375 is an FDA 510(k) premarket notification submitted by Tri-State Hospital Supply Corp. for the device "CENTURION STOPCOCK 3 WAY". The FDA issued a decision of Substantially Equivalent on February 26, 1981. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Tri-State Hospital Supply Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1981
- Date Received
- February 12, 1981
- 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