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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K943629
Device Name GIP/MEDI-GLOBE PAPILLOTOME
Applicant
MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE,  AZ  85283
Applicant Contact BRIAN KARLER
Correspondent
MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE,  AZ  85283
Correspondent Contact BRIAN KARLER
Regulation Number876.4300
Classification Product Code
KNS  
Date Received07/26/1994
Decision Date 05/26/1995
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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