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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 K051247
Device Name SONOTIP II ULTRASOUND NEEDLE SYSTEM
Applicant
MEDI-GLOBE CORP.
110 WEST ORION, SUITE 136
TEMPE,  AZ  85283
Applicant Contact SCOTT KARLER
Correspondent
MEDI-GLOBE CORP.
110 WEST ORION, SUITE 136
TEMPE,  AZ  85283
Correspondent Contact SCOTT KARLER
Regulation Number876.1075
Classification Product Code
FCG  
Date Received05/16/2005
Decision Date 06/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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