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510(k) K033735

VANTAGE PRO ATTENUATION CORRECTION DEVICE by Adac Laboratories — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2003
Date Received
November 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

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