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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 K211235
Device Name CIRCUL8 Luxe DVT Prevention Device
Applicant
Ortho8, Inc.
2217 Plaza Dr.
Rocklin,  CA  95765
Applicant Contact Taylor Nordeen
Correspondent
Medtech Review, LLC
257 Garnet Garden St.
Henderson,  NV  89015
Correspondent Contact John Beasley
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/26/2021
Decision Date 09/08/2021
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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