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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 K191466
Device Name SandShark Injectable Anchor (SIA) System
Applicant
Stimwave Technologies Inc.
1310 Park Central Boulevard South
Pompano Beach,  FL  33064
Applicant Contact Elizabeth Greene
Correspondent
Stimwave Technologies Inc.
1310 Park Central Boulevard South
Pompano Beach,  FL  33064
Correspondent Contact Elizabeth Greene
Regulation Number882.5880
Classification Product Code
GZB  
Date Received06/03/2019
Decision Date 11/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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