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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, spinal-cord, implanted (pain relief)
510(k) Number K141399
FOIA Releasable 510(k) K141399
Device Name FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
Applicant
STIMWAVE TECHNOLOGIES INCORPORATED
420 Lincoln Rd Suite 365
Miami Beach,  FL  33139
Applicant Contact Elizabeth Greene
Correspondent
STIMWAVE TECHNOLOGIES INCORPORATED
420 Lincoln Rd Suite 365
Miami Beach,  FL  33139
Correspondent Contact Elizabeth Greene
Regulation Number882.5880
Classification Product Code
GZB  
Date Received05/28/2014
Decision Date 10/10/2014
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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