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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
510(k) Number K051324
Device Name MEDI BUTLER
Applicant
Medi USA, LP
1800 Massachusetts Ave. NW
Washington,  DC  20036
Applicant Contact GARY L YINGLING
Correspondent
Medi USA, LP
1800 Massachusetts Ave. NW
Washington,  DC  20036
Correspondent Contact GARY L YINGLING
Regulation Number880.5780
Classification Product Code
DWL  
Date Received05/20/2005
Decision Date 12/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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