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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 K083822
Device Name LASER TOUCHONE
Applicant
LASER HEALTH TECHNOLOGIES, LLC
5600 WISCONSIN AVE.,
SUITE 509
CHEVY CHASE,  MD  20815
Applicant Contact Patsy Trisler
Correspondent
LASER HEALTH TECHNOLOGIES, LLC
5600 WISCONSIN AVE.,
SUITE 509
CHEVY CHASE,  MD  20815
Correspondent Contact Patsy Trisler
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
NHN  
Date Received12/22/2008
Decision Date 05/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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