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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K011261
Device Name STONE EXTRACTOR BALLOON CATHETER
Applicant
Medi-Globe Corp.
6202 S. Maple Ave. # 131
Tempe,  AZ  85283
Applicant Contact SCOTT KARLER
Correspondent
Medi-Globe Corp.
6202 S. Maple Ave. # 131
Tempe,  AZ  85283
Correspondent Contact SCOTT KARLER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/25/2001
Decision Date 11/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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