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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Traction, Powered
510(k) Number K843522
Device Name DONWAY SPLINT
Applicant
Australian Biomedical Corporation , Ltd.
447-459 Willianstown Rd.
Port Melbourne, Victoria 3207
Australia, 
Applicant Contact COOK
Correspondent
Australian Biomedical Corporation , Ltd.
447-459 Willianstown Rd.
Port Melbourne, Victoria 3207
Australia, 
Correspondent Contact COOK
Regulation Number890.5900
Classification Product Code
ITH  
Date Received09/07/1984
Decision Date 02/07/1985
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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