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510(k) K093713

ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM by Civco Medical Instruments — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2010
Date Received
December 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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