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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K172331
Device Name Type I, Type II, Type III, Type IV
Applicant
Lepu Medical Technology (Beijing) Co., Ltd.
# 37 Chaoqian Rd.
Beijing,  CN 102200
Applicant Contact Xiangdan Jin
Correspondent
FDA Regulatory and Quality Systems Consultant
31853 Cedar Rd.
Mayfield Heights,  OH  44124 -4445
Correspondent Contact Arthur Goddard
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/02/2017
Decision Date 03/02/2018
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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