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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 K940543
Device Name MODEL 777 THERAPEUTIC MASSAGER
Applicant
Voyager Medical Corp.
921 SW Wasington, Suite 880
Portland,  OR  97206
Applicant Contact GARY BINDER
Correspondent
Voyager Medical Corp.
921 SW Wasington, Suite 880
Portland,  OR  97206
Correspondent Contact GARY BINDER
Regulation Number890.5660
Classification Product Code
ISA  
Date Received02/07/1994
Decision Date 04/21/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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