510(k) K831747

PLASMA THERAPY TUBESET-E100 SERIES by Parker Hannifin Corp. — Product Code FJK

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