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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 K021654
Device Name REPROCESSED COMPRESSION SLEEVE
Applicant
ALLIANCE MEDICAL, INC.
10232 SOUTH 51 ST.
PHOENIX,  AZ  85044
Applicant Contact LORRI CHAVEZ
Correspondent
ALLIANCE MEDICAL, INC.
10232 SOUTH 51 ST.
PHOENIX,  AZ  85044
Correspondent Contact LORRI CHAVEZ
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/20/2002
Decision Date 02/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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