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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 K072260
Device Name NUFACE, MODEL NU-4003
Applicant
Carol Cole Company
3366 N. Torrey Pines Ct.
Suite 130
La Jolla,  CA  92037
Applicant Contact HOWARD ASHER
Correspondent
Carol Cole Company
3366 N. Torrey Pines Ct.
Suite 130
La Jolla,  CA  92037
Correspondent Contact HOWARD ASHER
Regulation Number882.5890
Classification Product Code
NFO  
Date Received08/14/2007
Decision Date 11/27/2007
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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