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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
Applicant
Jace Systems, Inc.
101 Foster Rd.
Moorestown,  NJ  08057
Applicant Contact RICK ROSATI
Correspondent
Jace Systems, Inc.
101 Foster Rd.
Moorestown,  NJ  08057
Correspondent 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 Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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