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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 K884132
Device Name TECNOL BUCKS TRACTION W/HEEL PROTECTOR
Applicant
Technol, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Applicant Contact LEONA M HAMMEL
Correspondent
Technol, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Correspondent Contact LEONA M HAMMEL
Regulation Number888.5890
Classification Product Code
KQZ  
Date Received09/30/1988
Decision Date 10/11/1988
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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