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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 K181062
Device Name Ultra Facial Toning System
Applicant
Micro Current Technology, Inc.
2244 1st Ave. S.
Seattle,  WA  98134
Applicant Contact David Suzuki
Correspondent
Regulatory Insight, Inc.
2244 1st Ave. S.
Seattle,  WA  98134
Correspondent Contact David Suzuki
Regulation Number882.5890
Classification Product Code
NFO  
Date Received04/23/2018
Decision Date 07/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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