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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 ROAD
PORT MELBOURNE, VICTORIA 3207
AUSTRALIA, 
Applicant Contact COOK
Correspondent
AUSTRALIAN BIOMEDICAL CORPORATION LTD.
447-459 WILLIANSTOWN ROAD
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
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