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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Traction, Non-Powered
510(k) Number K812779
Device Name EXTENSIONS-LUSATZTISCH
Applicant
The Telos Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
The Telos Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.5850
Classification Product Code
HST  
Date Received10/05/1981
Decision Date 10/26/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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