510(k) K861518

UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F) by Jufrey Multimed Corp. — Product Code FPA

K861518 is an FDA 510(k) premarket notification submitted by Jufrey Multimed Corp. for the device "UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F)". The FDA issued a decision of Substantially Equivalent on May 27, 1986. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Jufrey Multimed Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1986
Date Received
April 23, 1986
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