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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, Over-The-Counter
510(k) Number K172971
Device Name BMLS16-1
Applicant
BioMedical Life Systems, Inc.
P.O. Box 1360
Vista,  CA  92085 -1360
Applicant Contact Gary Bussett
Correspondent
BioMedical Life Systems, Inc.
P.O. Box 1360
Vista,  CA  92085 -1360
Correspondent Contact Gary Bussett
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
GZJ  
Date Received09/26/2017
Decision Date 07/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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