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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 K221376
Device Name Nalu Neurostimulation System
Applicant
Nalu Medical, Inc.
2320 Faraday Avenue, Suite 100
Carlsbad,  CA  92008
Applicant Contact Chelsea Gutierrez
Correspondent
Nalu Medical, Inc.
2320 Faraday Avenue, Suite 100
Carlsbad,  CA  92008
Correspondent Contact Chelsea Gutierrez
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received05/12/2022
Decision Date 06/10/2022
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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