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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biopsy needle
510(k) Number K070129
Device Name SONOTIP II ULTRASOUND NEEDLE SYSTEM
Applicant
MEDI-GLOBE CORPORATION
110 WEST ORION #136
TEMPE,  AZ  85283
Applicant Contact SCOTT KARLER
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number876.1075
Classification Product Code
FCG  
Date Received01/16/2007
Decision Date 01/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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