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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 K850771
Device Name OSTER MASSAGE WAND STICK MASSAGER 295-07
Applicant
Daito Electric Machine Industries Company, Ltd.
Oster
5055 N. Lydell Ave.
Milwaukee,  WI  53217
Applicant Contact JANICE A KARR
Correspondent
Daito Electric Machine Industries Company, Ltd.
Oster
5055 N. Lydell Ave.
Milwaukee,  WI  53217
Correspondent Contact JANICE A KARR
Regulation Number890.5660
Classification Product Code
ISA  
Date Received02/25/1985
Decision Date 05/14/1985
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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