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510(k) K041545

CONTACT DETACH by Unomedical A/S — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2004
Date Received
June 9, 2004
Clearance Type
Special
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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