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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 K131910
Device Name MPP
Applicant
MARC PRO
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
MARC PRO
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received06/26/2013
Decision Date 01/24/2014
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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