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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K160052
Device Name CUR Model 1
Applicant
Thimble Bioelectronics, Inc.
2011 26th St. Suite 202
San Francisco,  CA  94107
Applicant Contact Shaun Rahimi
Correspondent
Thimble Bioelectronics, Inc.
2011 26th St. Suite 202
San Francisco,  CA  94107
Correspondent Contact Shaun Rahimi
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received01/11/2016
Decision Date 05/20/2016
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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