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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K853836
Device Name NEURO PULSE II
Applicant
Nagata Engineering Co.
4926 La Cuenta Dr. Suite 203a
San Diego,  CA  92124
Applicant Contact TAKAO NAGATA
Correspondent
Nagata Engineering Co.
4926 La Cuenta Dr. Suite 203a
San Diego,  CA  92124
Correspondent Contact TAKAO NAGATA
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/17/1985
Decision Date 12/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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