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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic irrigation/suction system
510(k) Number K191366
Device Name Vacutore Air/Water Bottle Tubing
Smartdata Suzhou Co., Ltd
4f, Block 7, 198#, Jinshan Rd
suzhou,  CN 215011
Applicant Contact cindy ye
Accelerated Device Approval Services, LLC
6800 S.W. 40th Street, Ste. 444
ludlum,  FL  33155 -3708
Correspondent Contact rafael aguila
Regulation Number876.1500
Classification Product Code
Date Received05/22/2019
Decision Date 09/06/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No