510(k) K831747
K831747 is an FDA 510(k) premarket notification submitted by Parker Hannifin Corp. for the device "PLASMA THERAPY TUBESET-E100 SERIES". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Parker Hannifin Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1983
- Date Received
- June 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type