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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 K020592
Device Name ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
Applicant
Alba-Waldensian, Inc.
425 N Gateway Ave.
Rockwood,  TN  37854
Applicant Contact DAVID BOWMAN
Correspondent
Alba-Waldensian, Inc.
425 N Gateway Ave.
Rockwood,  TN  37854
Correspondent Contact DAVID BOWMAN
Regulation Number880.5780
Classification Product Code
DWL  
Date Received02/22/2002
Decision Date 04/03/2002
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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