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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, automatic carbon-dioxide for endoscope
510(k) Number K132192
Device Name BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR
Applicant
BRACCO DIAGNOSTIC, INC.
259 PROSPECT PLAINS ROAD
BUILDING H
MONROE TOWNSHIP,  NJ  08831
Applicant Contact TRACEY ALEXANDER
Correspondent
BRACCO DIAGNOSTIC, INC.
259 PROSPECT PLAINS ROAD
BUILDING H
MONROE TOWNSHIP,  NJ  08831
Correspondent Contact TRACEY ALEXANDER
Regulation Number876.1500
Classification Product Code
FCX  
Date Received07/15/2013
Decision Date 02/14/2014
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
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