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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 K201618
Device Name Nalu Neurostimulation SCS system
Applicant
Nalu Medical, Inc.
2320 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Applicant Contact Michele Chin-Purcell
Correspondent
Nalu Medical, Inc.
2320 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Correspondent Contact Pauline Lieu
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received06/15/2020
Decision Date 07/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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