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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K201794
Device Name Jade
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
#1st Jinkui Rd.
Futian Free Trade Zone
Shenzhen,  CN 518038
Applicant Contact Daniel Zhang
Correspondent
OrbusNeich Medical (Shenzhen) Co., Ltd.
#1st Jinkui Rd.
Futian Free Trade Zone
Shenzhen,  CN 518038
Correspondent Contact Daniel Zhang
Regulation Number870.1250
Classification Product Code
LIT  
Date Received06/30/2020
Decision Date 07/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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