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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Non-Invasive
510(k) Number K871296
Device Name T.E.D.(TM) TRACTION DEVICE
Applicant
The Kendal Co.
One Federal St.
Boston,  MA  02110 -2003
Applicant Contact CYNTHIA A ZAHOUR
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110 -2003
Correspondent Contact CYNTHIA A ZAHOUR
Regulation Number888.5890
Classification Product Code
KQZ  
Date Received03/31/1987
Decision Date 04/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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