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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name exerciser, finger, powered
510(k) Number K931016
Device Name JACE MODEL H440 HAND CPM DEVICE
Original Applicant
JACE SYSTEMS, INC.
101 foster rd.
moorestown,  NJ  08057
Original Contact rick rosati
Regulation Number890.5410
Classification Product Code
JFA  
Date Received02/26/1993
Decision Date 06/22/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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