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510(k) K120882

SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE by Bard Access Systems, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2012
Date Received
March 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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