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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 K131933
Device Name ELECTRONIC PULSE MASSAGER
Applicant
GURIN PRODUCTS, LLC
2522 CHAMBERS ROAD
SUITE 100
TUSTIN,  CA  92780
Applicant Contact SANJAY GUPTA
Correspondent
GURIN PRODUCTS, LLC
2522 CHAMBERS ROAD
SUITE 100
TUSTIN,  CA  92780
Correspondent Contact SANJAY GUPTA
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received06/27/2013
Decision Date 12/20/2013
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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