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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 K990220
Device Name MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
Applicant
Medi-Globe Corp.
6202 S. Maple Ave. # 131
Tempe,  AZ  85283
Applicant Contact MICHELLE L FIELDS
Correspondent
Medi-Globe Corp.
6202 S. Maple Ave. # 131
Tempe,  AZ  85283
Correspondent Contact MICHELLE L FIELDS
Regulation Number876.1075
Classification Product Code
FCG  
Date Received01/22/1999
Decision Date 03/31/1999
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
Predetermined Change
Control Plan Authorized		 No
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