510(k) K060352

HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS by Health Line International Corporation — Product Code FPA

K060352 is an FDA 510(k) premarket notification submitted by Health Line International Corporation for the device "HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS". The FDA issued a decision of Substantially Equivalent on May 31, 2006. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Health Line International Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2006
Date Received
February 13, 2006
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