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510(k) K033102

MEDIC COLON MODEL, RELEASE 1 by Medicsight — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2003
Date Received
September 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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