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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bit, Drill
510(k) Number K870217
Device Name FEMORAL CEMENT REMOVAL INSTRUMENTS
Applicant
Kenneth J. Hoek, M.D., Inc.
620 S. Dora
Ukiah,  CA  95482
Correspondent
Kenneth J. Hoek, M.D., Inc.
620 S. Dora
Ukiah,  CA  95482
Regulation Number888.4540
Classification Product Code
HTW  
Date Received01/21/1987
Decision Date 02/06/1987
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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