510(k) K895770

EXEL HUBER INFUSION SET by Exel Intl. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1990
Date Received
September 26, 1989
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