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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K920380
Device Name JACE MODEL W550 WRIST 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 Number890.5380
Classification Product Code
BXB  
Date Received01/29/1992
Decision Date 02/11/1992
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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