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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sleeve, limb, compressible
510(k) Number K173528
Device Name Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
Applicant
Devon Medical Products (Jiangsu) Ltd.
East Half of 1-2f, Appt D2
1, Qingfeng Road.
Nantong,  CN 226017
Applicant Contact Julian Chu
Correspondent
Devon Medical Products (Jiangsu) Ltd.
East Half of 1-2f, Appt D2
1, Qingfeng Road.
Nantong,  CN 226017
Correspondent Contact Julian Chu
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/15/2017
Decision Date 02/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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