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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K011935
Device Name REJUVENIQUE MODEL #RJV10
Applicant
Salton, Inc.
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact GEORGIA C RAVITZ
Correspondent
Salton, Inc.
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact GEORGIA C RAVITZ
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Code
GYB  
Date Received06/21/2001
Decision Date 08/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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