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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, peripheral nerve, implanted (pain relief)
510(k) Number K152178
Device Name StimQ Peripheral Nerve Stimulator (PNS) System
Applicant
STIMQ LLC
901 EAST LAS OLAS BOULEVARD, SUITE 201
FORT LAURDERDALE,  FL  33301
Applicant Contact ELIZABETH GREENE
Correspondent
STIMQ LLC
901 EAST LAS OLAS BOULEVARD, SUITE 201
FORT LAURDERDALE,  FL  33301
Correspondent Contact ELIZABETH GREENE
Regulation Number882.5870
Classification Product Code
GZF  
Date Received08/04/2015
Decision Date 03/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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