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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, Invasive
510(k) Number K903105
Device Name OLIVE K-WIRES
Applicant
Danek Medical, Inc.
3092 Director'S Row
Memphis,  TN  38131
Applicant Contact FRANK M LEWIS
Correspondent
Danek Medical, Inc.
3092 Director'S Row
Memphis,  TN  38131
Correspondent Contact FRANK M LEWIS
Regulation Number888.3040
Classification Product Code
JEC  
Date Received07/05/1990
Decision Date 09/06/1990
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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