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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 K181509
Device Name Endorate Valve Sets
Applicant
Smartdata Suzhou Co., Ltd
4f, Block 7, 198#, Jinshan Rd
Suzhou,  CN 215011
Applicant Contact Cindy Ye
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number876.1500
Classification Product Code
OCX  
Subsequent Product Code
ODC  
Date Received06/08/2018
Decision Date 07/06/2018
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
Recalls CDRH Recalls
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