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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 K090921
Device Name ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
Applicant
BEIERSDORF, INC.
187 DANBURY RD.
WILTON,  CT  06897
Applicant Contact PETER STRATTON
Correspondent
BEIERSDORF, INC.
187 DANBURY RD.
WILTON,  CT  06897
Correspondent Contact PETER STRATTON
Regulation Number880.5780
Classification Product Code
DWL  
Date Received04/01/2009
Decision Date 12/18/2009
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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