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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, conduction, anesthetic (w/wo introducer)
510(k) Number K121812
Model SONIXGPS NERVE BLOCK
Device Name SONIXGPS
Original Applicant
ULTRASONIX MEDICAL CORPORATION
57 lazy brook rd.
monroe,  CT  06468
Original Contact raymond kelly
Regulation Number868.5150
Classification Product Code
BSP  
Date Received06/20/2012
Decision Date 12/02/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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