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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, Over-The-Counter
510(k) Number K100116
FOIA Releasable 510(k) K100116
Device Name LASERTOUCHONE (OTC)
Applicant
LASER HEALTH TECHNOLOGIES, LLC
5600 WISCONSIN AVENUE
#509
CHEVY CHASE,  MD  20815
Applicant Contact PATSY J TRISLER
Correspondent
LASER HEALTH TECHNOLOGIES, LLC
5600 WISCONSIN AVENUE
#509
CHEVY CHASE,  MD  20815
Correspondent Contact PATSY J TRISLER
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NHN  
Date Received01/15/2010
Decision Date 04/15/2010
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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