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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K864088
Device Name HITACHI HAND HELD MASSAGER A/C POWERED
Applicant
Hitachi Sales Corporation of America
P.O. Box 92232
Los Angeles,  CA  90009
Applicant Contact DAVID DAVIS
Correspondent
Hitachi Sales Corporation of America
P.O. Box 92232
Los Angeles,  CA  90009
Correspondent Contact DAVID DAVIS
Regulation Number890.5660
Classification Product Code
ISA  
Date Received10/21/1986
Decision Date 11/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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