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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name goniometer, ac-powered
510(k) Number K943929
Device Name DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
Applicant
GREENLEAF MEDICAL SYSTEMS, INC.
2248 PARK BLVD.
PALO ALTO,  CA  94306
Applicant Contact GLENN R EDWARDS
Correspondent
GREENLEAF MEDICAL SYSTEMS, INC.
2248 PARK BLVD.
PALO ALTO,  CA  94306
Correspondent Contact GLENN R EDWARDS
Regulation Number888.1500
Classification Product Code
KQX  
Date Received08/12/1994
Decision Date 05/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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