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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 K823660
Device Name UNIVERSAL BUCKS TRACTION
Applicant
Warm & Form, Orthopedic Materials
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Warm & Form, Orthopedic Materials
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.5890
Classification Product Code
KQZ  
Date Received12/06/1982
Decision Date 12/30/1982
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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