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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, body composition
510(k) Number K051589
Device Name SLIMMANAGER, MODEL SM-X, SM-E
Applicant
AIIA COMMUNICATION INC.
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact JOHN MYUNG
Correspondent
AIIA COMMUNICATION INC.
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact JOHN MYUNG
Regulation Number870.2770
Classification Product Code
MNW  
Date Received06/15/2005
Decision Date 10/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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