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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, neuromuscular, external functional
510(k) Number K103366
Device Name RT600
Applicant
RESTORATIVE THERAPIES INC.
907 SOUTH LAKEWOOD AVE.
BALTIMORE,  MD  21224
Applicant Contact SCOTT SIMCOX
Correspondent
RESTORATIVE THERAPIES INC.
907 SOUTH LAKEWOOD AVE.
BALTIMORE,  MD  21224
Correspondent Contact SCOTT SIMCOX
Regulation Number882.5810
Classification Product Code
GZI  
Date Received11/16/2010
Decision Date 04/04/2011
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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