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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 K172103
Device Name Flowtron DVT5 Small Calf Garment
Applicant
Getinge (Suzhou) Co., Ltd.
No. 158 Fangzhou Road
Suzhou,  CN 2015024
Applicant Contact Daisy Qin
Correspondent
ArjoHuntleigh AB
35 Portmanmoor Road
Cardiff,  GB cf24 5hn
Correspondent Contact David Moynham
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/12/2017
Decision Date 03/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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