510(k) K853327

JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION by Jufrey Multimed Corp. — Product Code FPA

K853327 is an FDA 510(k) premarket notification submitted by Jufrey Multimed Corp. for the device "JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION". The FDA issued a decision of Substantially Equivalent on August 21, 1985. 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
August 21, 1985
Date Received
August 8, 1985
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