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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 K951727
Device Name Z-WATCH SYSTEM
Applicant
Prizm Medical, Inc.
3050 Business Park Dr.
Suite A2
Norcross,  GA  30071
Applicant Contact JAMES JOHNSON
Correspondent
Prizm Medical, Inc.
3050 Business Park Dr.
Suite A2
Norcross,  GA  30071
Correspondent Contact JAMES JOHNSON
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/13/1995
Decision Date 11/21/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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