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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 K083802
FOIA Releasable 510(k) K083802
Device Name SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
Applicant
MEDI-GLOBE CORPORATION
110 WEST ORION ST #136
TEMPE,  AZ  85283
Applicant Contact SCOTT KARLER
Correspondent
MEDI-GLOBE CORPORATION
110 WEST ORION ST #136
TEMPE,  AZ  85283
Correspondent Contact SCOTT KARLER
Regulation Number876.1075
Classification Product Code
FCG  
Date Received12/22/2008
Decision Date 03/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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