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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 K182150
Device Name Devon 52 Sequential Compression Device
Applicant
Devon Medical Products (Jiangsu), Ltd.
East Half Of 1-2f, Appt D2, 1, Qingfeng Rd.
Nantong,  CN 226017
Applicant Contact Neil Cheng
Correspondent
Devon MD, LLC
700 American Ave., Suite 100
King Of Prussia,  PA  19406
Correspondent Contact Ruth Wu
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/08/2018
Decision Date 12/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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