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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 -5339
Applicant Contact GEORGIA C RAVITZ
Correspondent
SALTON, INC.
1050 CONNECTICUT AVE., NW
WASHINGTON,  DC  20036 -5339
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
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