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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K180731
Device Name Ultramatrix EUS Balloon
Applicant
United States Endoscopy Group, Inc. (Us Endoscopy)
5976 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Coletta Cohara
Correspondent
United States Endoscopy Group, Inc. (Us Endoscopy)
5976 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Coletta Cohara
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Code
ITX  
Date Received03/20/2018
Decision Date 04/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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