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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Peripheral Nerve, Implanted (Pain Relief)
510(k) Number K202781
Device Name Neuspera Neurostimulation System (NNS)
Applicant
Neuspera Medical, Inc.
51 Daggett Dr.
San Jose,  CA  95134
Applicant Contact Alexander Yeh
Correspondent
Neuspera Medical, Inc.
51 Daggett Dr.
San Jose,  CA  95134
Correspondent Contact Alexander Yeh
Regulation Number882.5870
Classification Product Code
GZF  
Date Received09/22/2020
Decision Date 08/27/2021
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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