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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 K921000
Device Name SONACARE SOUND MASSAGER
Applicant
Honor Trading, Ltd.
3589 Yale Way
Fremont,  CA  94538
Applicant Contact LISA MORTON
Correspondent
Honor Trading, Ltd.
3589 Yale Way
Fremont,  CA  94538
Correspondent Contact LISA MORTON
Regulation Number890.5660
Classification Product Code
ISA  
Date Received02/27/1992
Decision Date 03/31/1993
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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