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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator, Therapeutic
510(k) Number K850495
Device Name AKUFON THERAPEUTIC MASSAGER
Applicant
Jansson A/S
Kirketorvet 18
Vejle,  DK
Applicant Contact ORUM MEIER
Correspondent
Jansson A/S
Kirketorvet 18
Vejle,  DK
Correspondent Contact ORUM MEIER
Regulation Number890.5975
Classification Product Code
IRO  
Date Received02/08/1985
Decision Date 01/03/1986
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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