510(k) K790062

IV ADMINISTRATION SET WITH BACKCHECK by National Patent Development Corp. — Product Code FPA

K790062 is an FDA 510(k) premarket notification submitted by National Patent Development Corp. for the device "IV ADMINISTRATION SET WITH BACKCHECK". The FDA issued a decision of Substantially Equivalent on April 10, 1979. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. National Patent Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1979
Date Received
January 10, 1979
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