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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 K881603
Device Name ULTRA TRACTION
Applicant
COMPONENT EQUIPMENT MFG., INC.
615 CONRAD ST.
COLORADO SPRINGS,  CO  80915
Applicant Contact TIMOTHY J JUNK
Correspondent
COMPONENT EQUIPMENT MFG., INC.
615 CONRAD ST.
COLORADO SPRINGS,  CO  80915
Correspondent Contact TIMOTHY J JUNK
Regulation Number890.5900
Classification Product Code
ITH  
Date Received04/13/1988
Decision Date 05/04/1988
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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