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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 K211200
Device Name WoundExpress
Applicant
Huntleigh Healthcare , Ltd.
35 Portmanmoor Rd.
Cardiff,  GB CF24 5HN
Applicant Contact Steve Monks
Correspondent
Huntleigh Healthcare , Ltd.
35 Portmanmoor Rd.
Cardiff,  GB CF24 5HN
Correspondent Contact Steve Monks
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/22/2021
Decision Date 09/03/2021
Decision Substantially Equivalent (SESE)
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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