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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 K180981
Device Name Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
Applicant
Stimwave Technologies Incorporated
1310 Park Central Boulevard South
Pompano Beach,  FL  33064
Applicant Contact Elizabeth Greene
Correspondent
Stimwave Technologies Incorporated
1310 Park Central Boulevard South
Pompano Beach,  FL  33064
Correspondent Contact Elizabeth Greene
Regulation Number882.5880
Classification Product Code
GZB  
Date Received04/13/2018
Decision Date 09/19/2018
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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