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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 K073542
Device Name CYCLETRAC CT-5000
Applicant
PT PRODUCTS, LLC
24543 INDOPLEX CIRCLE
FARMINGTON HILLS,  MI  48335
Applicant Contact MICHELE CONWAY
Correspondent
PT PRODUCTS, LLC
24543 INDOPLEX CIRCLE
FARMINGTON HILLS,  MI  48335
Correspondent Contact MICHELE CONWAY
Regulation Number890.5900
Classification Product Code
ITH  
Date Received12/17/2007
Decision Date 02/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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