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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K993461
Device Name QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
Applicant
Icon Intl., LLC
300 Ozark Trl. Dr., #207c
Ellisville,  MO  63011
Applicant Contact GERALD S AUSLANDER
Correspondent
Icon Intl., LLC
300 Ozark Trl. Dr., #207c
Ellisville,  MO  63011
Correspondent Contact GERALD S AUSLANDER
Regulation Number890.5880
Classification Product Code
JFB  
Date Received10/13/1999
Decision Date 01/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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