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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 K101035
Device Name WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000
Applicant
Wmi Enterprises, LLC
1017 W. Washington, 2j
Chicago,  IL  60607
Applicant Contact MIKE WILFORD
Correspondent
Wmi Enterprises, LLC
1017 W. Washington, 2j
Chicago,  IL  60607
Correspondent Contact MIKE WILFORD
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/14/2010
Decision Date 10/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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