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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 K910519
Device Name GOOD VIBRATIONS TUBE MASSAGER
Applicant
Dual Voltage, Inc.
901 Santerre Dr.
Grand Prairie,  TX  75050
Applicant Contact DAVID L FRENCH
Correspondent
Dual Voltage, Inc.
901 Santerre Dr.
Grand Prairie,  TX  75050
Correspondent Contact DAVID L FRENCH
Regulation Number890.5660
Classification Product Code
ISA  
Date Received02/07/1991
Decision Date 04/01/1991
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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