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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 K925643
Device Name RX FIT MEDICAL STOCKINGS
Applicant
Elastic Therapy, Inc.
1617 N. Fayetteville St.
P.O. Box 4068
Ashboro,  NC  27204
Applicant Contact NEAL HUGHES
Correspondent
Elastic Therapy, Inc.
1617 N. Fayetteville St.
P.O. Box 4068
Ashboro,  NC  27204
Correspondent Contact NEAL HUGHES
Regulation Number880.5780
Classification Product Code
DWL  
Date Received11/09/1992
Decision Date 12/06/1993
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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