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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 K070250
Device Name NUTRITONE FACIAL BEAUTY SYSTEM
Applicant
ISOMERS LABORATORIES INC.
11 DELLCASTLE COURT
MONTGOMERY VILLAGE,,  MD  20886
Applicant Contact ROBERT MAZZAFERRO
Correspondent
ISOMERS LABORATORIES INC.
11 DELLCASTLE COURT
MONTGOMERY VILLAGE,,  MD  20886
Correspondent Contact ROBERT MAZZAFERRO
Regulation Number882.5890
Classification Product Code
NFO  
Date Received01/26/2007
Decision Date 09/04/2008
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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