510(k) K842858

FLUID ADMINISTRATION LINE W/SPIKE 14-923 by Norton Performance Plastics Corp. — Product Code FPA

K842858 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "FLUID ADMINISTRATION LINE W/SPIKE 14-923". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1984
Date Received
July 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type