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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K931781
Device Name JACE TRI-STIM 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 Number890.5850
Classification Product Code
IPF  
Date Received04/09/1993
Decision Date 10/08/1993
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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