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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 K202274
Device Name Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
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  92009
Correspondent Contact Pauline Lieu
Regulation Number882.5880
Classification Product Code
GZB  
Date Received08/11/2020
Decision Date 11/09/2020
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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