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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 K233801
Device Name Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
Applicant
Boston Scientific Neuromodulation
25155 Rye Canyon Loop
Valencia,  CA  91355
Applicant Contact Kaoru Lee Adair
Correspondent
Boston Scientific Neuromodulation Corp.
25155 Rye Canyon Loop
Valencia,  CA  92008
Correspondent Contact Kaoru Lee Adair
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received11/29/2023
Decision Date 08/23/2024
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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