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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 K121305
Device Name STERLING MEDICAL IMPULSE 3 STIMULATOR
Applicant
Armstrong Industries, Inc. Dha Mediquip Int. Dha S
7290 Virginia Pkwy.
Suite 3000
Mckinney,  TX  75071
Applicant Contact RALPH H ARMSTRONG
Correspondent
Armstrong Industries, Inc. Dha Mediquip Int. Dha S
7290 Virginia Pkwy.
Suite 3000
Mckinney,  TX  75071
Correspondent Contact RALPH H ARMSTRONG
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   LIH  
Date Received05/01/2012
Decision Date 09/25/2012
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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