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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 K041877
Device Name ACU-STRAP MOTION SICKNESS BAND
Applicant
Health Ent., Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact DANIEL J DILLON
Correspondent
Health Ent., Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact DANIEL J DILLON
Classification Product Code
MVV  
Date Received07/12/2004
Decision Date 10/08/2004
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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