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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 K153704
Device Name Strive
Applicant
DJO, LLC
1430 DECISION ST.
VISTA,  CA  92081
Applicant Contact Rand Daoud
Correspondent
DJO, LLC
1430 DECISION ST.
VISTA,  CA  92081
Correspondent Contact Rand Daoud
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
NUH   NYN  
Date Received12/23/2015
Decision Date 06/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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