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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, acupressure
510(k) Number K053509
Device Name ACUBAND ACUPRESSURE WRIST BAND DEVICE
Applicant
ACUBAND INC.
101 LITTLE SILVER POINT ROAD
LITTLE SILVER,  NJ  07739
Applicant Contact RICHARD GRIFFITH
Correspondent
ACUBAND INC.
101 LITTLE SILVER POINT ROAD
LITTLE SILVER,  NJ  07739
Correspondent Contact RICHARD GRIFFITH
Classification Product Code
MVV  
Date Received12/16/2005
Decision Date 08/16/2006
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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