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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
Model 32030
Device Name STERLING MEDICAL IMPULSE 3 STIMULATOR
Original Applicant
ARMSTRONG INDUSTRIES, INC. DHA MEDIQUIP INT. DHA STERLING ME
7290 virginia parkway
suite 3000
mckinney,  TX  75071
Original 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 (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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