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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K113724
Device Name ELECTROPULSE-COSMETIC
Applicant
PAIN RELIEF TECHNOLOGIES
15048 SW CAPSTONE CT.
BEAVERTON,  OR  97007
Applicant Contact KENDALL GORHAM
Correspondent
PAIN RELIEF TECHNOLOGIES
15048 SW CAPSTONE CT.
BEAVERTON,  OR  97007
Correspondent Contact KENDALL GORHAM
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Code
ILY  
Date Received12/19/2011
Decision Date 02/15/2012
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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