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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 K954295
Device Name MARLENE STOCKINGS & TIGHTS
Applicant
PROFESSIONAL PRODUCTS, INC.
6727 STOUT RD.
MEMPHIS,  TN  38119
Applicant Contact MARGARET J KIME
Correspondent
PROFESSIONAL PRODUCTS, INC.
6727 STOUT RD.
MEMPHIS,  TN  38119
Correspondent Contact MARGARET J KIME
Regulation Number880.5780
Classification Product Code
DWL  
Date Received09/14/1995
Decision Date 11/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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