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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
Applicant
UltraSonix Medical Corporation
57 Lazy Brook Rd.
Monroe,  CT  06468
Applicant Contact RAYMOND KELLY
Correspondent
UltraSonix Medical Corporation
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact RAYMOND KELLY
Regulation Number868.5150
Classification Product Code
BSP  
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
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