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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dynamometer, Ac-Powered
510(k) Number K935757
Device Name GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM
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 Number888.1240
Classification Product Code
LBB  
Date Received11/26/1993
Decision Date 04/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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