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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 K161484
Device Name ZIIP Device
Applicant
ZIIP,LLC
1871 Trestle Glen Rd.,
Piedmont,  CA  94610
Applicant Contact David Mason
Correspondent
ZIIP,LLC
1871 Trestle Glen Rd.,
Piedmont,  CA  94610
Correspondent Contact David Mason
Regulation Number882.5890
Classification Product Code
NFO  
Date Received05/31/2016
Decision Date 02/24/2017
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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