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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name forceps, biopsy, non-electric
510(k) Number K941359
Device Name GIP/MEDI-GLOBE BIOPSY FORCEPS
Applicant
MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE,  AZ  85283
Applicant Contact GINA M GALLOGOS
Correspondent
MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE,  AZ  85283
Correspondent Contact GINA M GALLOGOS
Regulation Number876.1075
Classification Product Code
FCL  
Date Received03/21/1994
Decision Date 07/12/1994
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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