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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 K894071
Device Name COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE
Applicant
Sara Lee Corp.
470 Hanes Mill Rd.
P.O. Box 2760
Winston-Salem,  NC  27102
Applicant Contact CHARLES LACKEY
Correspondent
Sara Lee Corp.
470 Hanes Mill Rd.
P.O. Box 2760
Winston-Salem,  NC  27102
Correspondent Contact CHARLES LACKEY
Regulation Number880.5780
Classification Product Code
DWL  
Date Received06/08/1989
Decision Date 10/18/1989
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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