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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 K031996
Device Name EXTENTRAC ELITE
Applicant
ADVANCED BACK TECHNOLOGIES
227 JACKSON AVE.
SYOSSET,  NY  11791
Applicant Contact DAVID F CUCCIA
Correspondent
ADVANCED BACK TECHNOLOGIES
227 JACKSON AVE.
SYOSSET,  NY  11791
Correspondent Contact DAVID F CUCCIA
Regulation Number890.5900
Classification Product Code
ITH  
Date Received06/27/2003
Decision Date 07/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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