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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K012616
Device Name CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR
Applicant
Clearmedical, Inc.
1776 136th Pl. NE
Bellevue,  WA  98005
Applicant Contact RICHARD RADFORD
Correspondent
Clearmedical, Inc.
1776 136th Pl. NE
Bellevue,  WA  98005
Correspondent Contact RICHARD RADFORD
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/13/2001
Decision Date 02/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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