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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 K935844
Device Name GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA
Applicant
MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE,  AZ  85283
Applicant Contact BRIAN J KARLER
Correspondent
MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE,  AZ  85283
Correspondent Contact BRIAN J KARLER
Regulation Number876.1075
Classification Product Code
FCG  
Date Received12/08/1993
Decision Date 02/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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