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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 K863699
Device Name SHEER ENERGY, ACTIVE & SILKY SUPPORT PANTY HOSE
Applicant
Hanes Group
Post Office Box 2760
Winston-Salem,  NC  27102
Applicant Contact CHARLES Y LACKEY
Correspondent
Hanes Group
Post Office Box 2760
Winston-Salem,  NC  27102
Correspondent Contact CHARLES Y LACKEY
Regulation Number880.5780
Classification Product Code
DWL  
Date Received09/23/1986
Decision Date 02/04/1987
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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