510(k) K800878

SECONDARY I.V. TUBING SETS by Harvard Laboratories — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1980
Date Received
April 17, 1980
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