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510(k) K023368

TRUCATH.IP by Aortech Critical Care , Ltd. — Product Code DFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2002
Date Received
October 8, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lambda, Rhodamine, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type