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510(k) K182281

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech by C. R. Bard — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2018
Date Received
August 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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  • K112791 — SITESCRUB IPA DEVICE (February 24, 2012)

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