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510(k) K071231

EDAC QUANTIFIER by Luna Innovations, Inc. — Product Code KRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2007
Date Received
May 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Detector, Bubble, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4205
Review Panel
CV
Submission Type

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