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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 K233525
Device Name MF SC Facial Toning System
Applicant
Micro Current Technology, Inc.
2244 1st Ave South
Seattle,  WA  98134
Applicant Contact David Suzuki
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number882.5890
Classification Product Code
NFO  
Date Received11/01/2023
Decision Date 11/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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