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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K153264
Device Name EasyPass Guidewire
Applicant
MEDI-GLOBE CORPORATION
7850 SOUTH HARDY DRIVE
STE. 112
TEMPE,  AZ  85284
Applicant Contact SCOTT KARLER
Correspondent
MEDI-GLOBE CORPORATION
7850 SOUTH HARDY DRIVE
STE. 112
TEMPE,  AZ  85284
Correspondent Contact SCOTT KARLER
Regulation Number876.1500
Classification Product Code
OCY  
Date Received11/12/2015
Decision Date 05/19/2016
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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