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510(k) K051264

COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS by Unomedical A/S — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2005
Date Received
May 16, 2005
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

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