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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
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
Date Received06/20/2012
Decision Date 12/02/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No