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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 K183631
Device Name medi pneumatic compression system (pcs) – brio (Model 651)
Applicant
Medi USA, LP
6481 Franz Warner Pkwy.
Whitsett,  NC  27377
Applicant Contact Glenn Anderson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/26/2018
Decision Date 01/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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