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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K840995
Device Name ACUPUNCTURE INSOLES
Applicant
LU LU ENTERPRISE CO. LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LU LU ENTERPRISE CO. LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Classification Product Code
BWK  
Date Received03/08/1984
Decision Date 03/27/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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