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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K972147
Device Name PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2)
Applicant
Dynamic Systems, Inc.
5002 N. Royal Atlanta Dr., #P
Tucker,  GA  30084
Applicant Contact DAVID R COURT
Correspondent
Dynamic Systems, Inc.
5002 N. Royal Atlanta Dr., #P
Tucker,  GA  30084
Correspondent Contact DAVID R COURT
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/09/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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