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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 K884723
Device Name (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM
Applicant
Greenleaf Medical Systems, Inc.
2248 Park Blvd.
Palo Alto,  CA  94306
Applicant Contact SEELIG, PHD
Correspondent
Greenleaf Medical Systems, Inc.
2248 Park Blvd.
Palo Alto,  CA  94306
Correspondent Contact SEELIG, PHD
Regulation Number888.1500
Classification Product Code
KQX  
Date Received11/10/1988
Decision Date 02/08/1989
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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