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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
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